BladderScan Prime PLUS System

K172356

Verathon Incorporated · cleared 2017-09-15 · product code IYO · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.7)

“The BladderScan® PRIME PLUS system is an ultrasound device intended to be used for measuring urine volume of the bladder non-invasively. The system calculates the bladder volume using patented neural network technology.”

Algorithmpatented neural network technology

source quote (p.7)

“The system calculates the bladder volume using patented neural network technology.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

endpoints: electrical safety; thermal safety; mechanical safety; EMC safety; cleaning/disinfection; biocompatibility; acoustic output

standards: ANSI/AAMI/ISO 10993-1:2009, ANSI/AAMI/ ISO 10993-5:2009, ISO 10993-10:2010, ANSI/AAMI/ISO 10993-12:2012, IEC 60601-1:2005/A1:2012, IEC 60601-1-2:2007, IEC 60601-2-37:2007, AIUM/NEMA UD-2:2004, AIUM AOMS:2004, ISO 14971:2007, IEC 60601-1-6 Edition 3.1 2013-10, AAMI HE 75:2009, IEC 62366-1:2015, ISO 13485:2003

Reported performance (2 observations)

accuracyas written: “Measurement Accuracy (0-100mL)”stated without valueCI ±7.5mL

source quote (p.8)

“0-100mL = ±7.5mL”

accuracyas written: “Measurement Accuracy (100-999 mL)”stated without valueCI ±7.5%

source quote (p.8)

“100-999 mL = ±7.5%”

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

recalls in product code, 24mo

344

MAUDE reports in code, 12mo

-40%

vs code's own 3-yr baseline

drift signals on this device

recall_reason_pattern
Software/algorithm-related recall in product code IYO (Civco Medical Instruments Co. Inc., initiated 2026-03-02): "There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98513

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). 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).