Saranas Early Bird Bleed Monitoring System

K230273

Saranas Inc. · cleared 2023-05-25 · product code QFJ · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.4)
“An intravascular bleed monitor is a probe, catheter, or catheter introducer that measures changes in bioimpedance and uses an algorithm to detect or monitor progression of potential internal bleed complications. The Early Bird consists of the following: introducer sheath, user interface display (UID), for the early detection and monitoring of potential internal bleeding complications (IBCs), and a compatible dilator as shown in Figure 1.”
AlgorithmThe device measures changes in bioimpedance and uses an algorithm to detect or monitor progression of potential internal bleed complications. The enhanced algorithm triggers a Level 1 bleed detection upon either an impedance drop threshold from a baseline impedance value or a bioimpedance drop rate that exceeds a slope threshold.
source quote (p.4)
“An intravascular bleed monitor is a probe, catheter, or catheter introducer that measures changes in bioimpedance and uses an algorithm to detect or monitor progression of potential internal bleed complications. This software release augments the detection algorithm by integrating an additional detection scheme based on an impedance drop threshold to supplement the current detection algorithm. The enhanced algorithm triggers a Level 1 bleed detection upon either an impedance drop threshold from a baseline impedance value or a bioimpedance drop rate that exceeds a slope threshold: the later trigger criterion being identical to the predicate device trigger criterion.”
Adaptive (vs locked)No
source quote (p.8)
“The reset allows the clinician to initiate a new, real-time bleed monitoring session to account for situations involving active bleeding, or when the device becomes accidentally dislodged. The reset restores the device to the original factory settings.”
PCCPFDA source did not state this
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

endpoints: packaging and sterile barrier requirements; electrical performance requirements; mechanical performance requirements

standards: ISO standards, ASTM standards

Bench

sample size not stated

standards: IEC 62304:2006, ISO 13485:2016, 21 CFR Part 820, ISO 14971:2019

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
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Saranas, Inc.) — same firm and product code, not necessarily this device · initiated 2022-08-10

    Bleed monitoring system device design error, causing the device to not power on and complete the series of self-tests so instructions for use being updated to include device check before use ensure that the device is functioning appropriately.

    recall event 90725 (openFDA)

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/K230273