Steth IO

K160016

STRATOSCIENTIFIC, INC. · cleared 2016-07-15 · product code DQD · Cardiovascular

Premarket evidence — what FDA accepted

Device typesimd
source quote (p.4)
“Steth IO is an acoustic device that is used in conjunction with a smartphone to collect heart and lung sounds. Steth IO attaches to the back of the smartphone and contains an acoustic wave guide that channels sound from the Steth IO chest piece to the smartphone's microphone, while also acting as a protective covering for the phone. The Steth IO smartphone application software performs real-time analysis so the user can hear the sounds using headphones, and visualize the sound using the on-screen phonocardiogram.”
Algorithmreal-time analysis
source quote (p.4)
“The Steth IO smartphone application software performs real-time analysis so the user can hear the sounds using headphones, and visualize the sound using the on-screen phonocardiogram.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

standards: CFR 21CFR820, IEC 62304:2006, ISO 13485:2012, ISO 14971:2012, ASTM D 4169:2009, IEC 60601-1:2005, EN 1041:2008, ISO 15223-1:2012, ISO 10993:2010

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

0
recalls in product code, 24mo
1
MAUDE reports in code, 12mo
+200%
vs code's own 3-yr baseline
0
drift signals on this device

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 2026-07-08.

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 Cardiovascular 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.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K160016