510(k) Report

510(k) · Cleared

Cleared

The Kendall Urinary Output Monitor

K852083510(k) TraditionalCleared Sep 20, 1985130-day reviewClass I21 CFR 876.4730

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

The Kendal Co. · FFO Retractor, Self-Retaining

Cleared on Sep 20, 1985 after a 130-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 20, 1985
Review
130 days
Class
Class I
Product code
FFO
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K852083Source: 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 FFO? 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 FFO devices

FFO Retractor, Self-Retaining: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FFO

FDA has decided no FFO device since 2007.

Median 510(k) review, days · FFO

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

Recalls per year · FFO

1in 2024

2015: 22024: 1
2007high 2 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FFO

2in 2025

2007: 12008: 22009: 12010: 22011: 22015: 22016: 322017: 202018: 22019: 42020: 22022: 32023: 22025: 2
2007high 32 (2016) · low 0 (2012)2025

MAUDE reports naming product code FFO, 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—01
20080—02
20090—01
20100—02
20110—02
20120—00
20130—00
20140—00
20150—22
20160—032
20170—020
20180—02
20190—04
20200—02
20210—00
20220—03
20230—02
20240—10
20250—02
20260—0—

More from The Kendal Co.

63 FDA decisions under this applicant name. See the company

  • K000087Marhukar Triple Lumen Catheter, Model 12 FRThe Kendal Co. · 2000
  • K990500Kendall Ultramer Coude Foley Catheter, Model 1416C, Kendall Curity Coude Foley Catheter Tray, Model 6946CThe Kendal Co. · 19991 Class I recall
  • K991758Monoject Insulin SyringeThe Kendal Co. · 1999
  • K970969Kendall Curity Suprapubic Catheter Tray, Kit, & Replacement SetThe Kendal Co. · 1997
  • K951488Kendall Curity Catheter Plug with Protective CapThe Kendal Co. · 1995

Recent decisions in FFO

The FFO category page

  • K993544Space-or RetractorAdvanced Surgical Concepts (Asc) · 1999
  • K870897Kodner Anal Perioneal RetractorSur-Med Instruments, Inc. · 1987
  • K860368Urdyn 5000 (Uroflowmeter)Dantec Electronics, Inc. · 1986
  • K853119Urodyn 1000Dantec Electronics, Inc. · 1985

https://510kreport.com/device/K852083 · printed Nov 4, 2026

Cite this page

510(k) Report. “K852083: The Kendall Urinary Output Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K852083

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