KOSMOS

K193518

EchoNous, Inc. · cleared 2020-03-26 · product code IYN · Radiology

FDA 510(k) summary for KOSMOS (K193518)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
1
Cited predicates
2
Performance observations
0
Product code
IYN
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.4)
“KOSMOS consists of a tablet and probe, which connects to the tablet via a cable. Its accessories include a power charger, ECG cable, and binaural headset. KOSMOS can operate on battery or while connected to mains. The probe face houses an ultrasound transducer and sealed microphones for auscultation. The tablet can display clinical and patient data information including the display of ultrasound images, auscultation and ECG waveforms, and patient data/reports.”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

standards: ANSI AAMI ES60601-1:2005/(R)2012 ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD), ANSI AAMI IEC 60601-2-27:2011(R)2016 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (limited set of test requirements), ANSI AAMI EC53:2013 ECG Trunk Cables And Patient Leadwires (limited set of test requirements), ANSI AAMI IEC 60601-1-2:2014 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests, IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability, ANSI AAMI IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices, IEC 60601-2-37 Edition 2.1 2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3, IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, ANSI AAMI IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes [Including Amendment 1 (2016)], ANSI AAMI ISO 10993-1:2009/(R)2013 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, ANSI AAMI ISO 14971:2007/(R)2010 (Corrected 4 October 2007) Medical devices - Applications of risk management to medical devices

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

25
recalls in product code, 24mo
594
MAUDE reports in code, 12mo
+95%
vs code's own 3-yr baseline
8
drift signals on this device
  • predicate_cohort_contagion

    K193518 shares predicate K180995 with K200232 (LVivo Software Application), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-08-26 · predicate:K180995 sibling:K200232

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K233826 (decision 2024-08-29) from EchoNous, Inc. for a matching device line ("Kosmos") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K233826

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K212100 (decision 2021-08-06) from EchoNous, Inc. for a matching device line ("Kosmos") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K212100

  • adverse_event_inflection

    MAUDE adverse-event reports for product code IYN: 604 in the 12 months ending 2026-06, vs a 298.7/12mo average over the prior 3 windows (+102%). Code-level count — reports are not attributed to this specific device.

    first seen 2026-07-15 · openFDA /device/event.json count=date_received product_code=IYN

  • recall_reason_pattern

    Software/algorithm-related recall in product code IYN (Philips Ultrasound, LLC, initiated 2025-10-31): "Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97843

  • recall_reason_pattern

    Software/algorithm-related recall in product code IYN (GE Medical Systems, LLC, initiated 2025-09-18): "The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinica" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97726

  • …and 2 more.

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-08-26.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Related FDA clearances

More AI/ML devices under product code IYN

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K193518