510(k) Report

510(k) · Cleared

Cleared

Unometer 500

K896732510(k) TraditionalCleared Nov 2, 1990337-day reviewClass II21 CFR 876.1800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Unoplast A/S · EXR Urinometer, Mechanical

Cleared on Nov 2, 1990 after a 337-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 2, 1990
Review
337 days
Class
Class II
Product code
EXR
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K896732Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EXR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All EXR devices

EXR Urinometer, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EXR

FDA has decided no EXR device since 2007.

Median 510(k) review, days · EXR

Too few EXR 510(k)s in any year since 2007 to give a median.

Recalls per year · EXR

No recall names EXR since 2007.

Adverse event reports per year · EXR

1in 2022

2009: 12011: 12013: 32014: 312015: 612016: 32022: 1
2007high 61 (2015) · low 0 (2007)2025

MAUDE reports naming product code EXR, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—01
20100—00
20110—01
20120—00
20130—03
20140—031
20150—061
20160—03
20170—00
20180—00
20190—00
20200—00
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—

More from Unoplast A/S

7 FDA decisions under this applicant name. See the company

  • K896734Feeding TubeUnoplast A/S · 19901 recall
  • K896729Nelaton-, Female - or Tiemann CatheterUnoplast A/S · 199014 recalls
  • K896731Oxygen CathetersUnoplast A/S · 1990
  • K896730Suction Catheter Straight/CoudeUnoplast A/S · 1990
  • K896733VacconUnoplast A/S · 1990

Recent decisions in EXR

The EXR category page

  • K934142Urinary Drainage BagKey Medical Services, Inc. · 1994
  • K935578Urine MeterPuritas Health Care, Inc. · 1993
  • K911258Kendall Pediatric Urine MeterKendall Healthcare Products Co. Div.Of Tyco Health · 1991
  • K870240Compress and Skullcap, Head DressingFraass Survival Systems, Inc. · 1987
  • K771561Dover Urine MeterWill Ross Co. · 1977

https://510kreport.com/device/K896732 · printed Nov 4, 2026

Cite this page

510(k) Report. “K896732: Unometer 500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K896732

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026