510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K813641Substantially Equivalent

Vital Metrics Urine Monitoring System

Vital Metrics, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813641 is the FDA 510(k) clearance record for VITAL METRICS URINE MONITORING SYSTEM, a class II device, cleared for Vital Metrics, Inc. on under FDA product code FFG (Device, Urine Flow Rate Measuring, Non-Electrical, Disposable). FDA records list 9 510(k) clearances for Vital Metrics, Inc., from to . As of , FDA records show no recalls naming K813641.

Clearance record

Decision date
Received
(61 days to decision)
Product code
FFG Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
Regulation
21 CFR 876.1800
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Vital Metrics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FFG

Trailing 12 months

FDA records hold no clearances under product code FFG in the trailing twelve months.

FDA records show no clearances under product code FFG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FFG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260