510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K896732Substantially Equivalent

Unometer 500

Unoplast A/S, Denmark, DK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896732 is the FDA 510(k) clearance record for UNOMETER 500, a class II device, cleared for Unoplast A/S on under FDA product code EXR (Urinometer, Mechanical). FDA records list 7 510(k) clearances for Unoplast A/S, from to . As of , FDA records show no recalls naming K896732.

Clearance record

Decision date
Received
(337 days to decision)
Product code
EXR Urinometer, Mechanical
Regulation
21 CFR 876.1800
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Unoplast A/S Dk-3390 Hundested, Denmark, DK
Third party review
No

Clearances, product code EXR

Trailing 12 months

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

FDA records show no clearances under product code EXR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EXR, 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