BladderScan Prime PLUS System— 510(k) K172356

Name: FDA 510(k) clearance K172356
Creator: U.S. Food and Drug Administration
Published: 2017-09-15

Substantially Equivalent

Verathon Incorporated

FDA 510(k) clearance K172356 for BladderScan Prime PLUS System, Substantially Equivalent on 2017-09-15. Applicant: Verathon Incorporated. Device class: 2.

Clearance details

Applicant: Verathon Incorporated
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2017-08-03
Decision date: 2017-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K172356

K-number listed on FDA's recall record

Z-0531-2021 — BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively.Class II·Terminated·Verathon, Inc.·20200929

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172356.

Data sourced from openFDA. This site is unofficial and independent of the FDA.