510(k) Report

510(k) · Cleared

Cleared

Monitor/Vital Signs Tray

K811915510(k) TraditionalCleared Jul 28, 198127-day reviewClass I21 CFR 880.6265

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

American Hospital Supply Corp. · FME Gown, Examination

Cleared on Jul 28, 1981 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 28, 1981
Review
27 days
Class
Class I
Product code
FME
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K811915Source: 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.

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  • 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 FME devices

FME Gown, Examination: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FME

FDA has decided no FME device since 2007.

Median 510(k) review, days · FME

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

Recalls per year · FME

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · FME

1in 2021

2011: 12012: 12016: 12018: 12021: 1
2007high 1 (2011) · low 0 (2007)2025

MAUDE reports naming product code FME, 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—10
20100—00
20110—01
20120—01
20130—00
20140—00
20150—00
20160—01
20170—00
20180—01
20190—00
20200—00
20210—01
20220—00
20230—00
20240—00
20250—00
20260—0—

More from American Hospital Supply Corp.

56 FDA decisions under this applicant name. See the company

  • K854739American Sterile Surgical Absorbent TowelAmerican Hospital Supply Corp. · 1985
  • K854759American Sterile Mayo Stand TrayAmerican Hospital Supply Corp. · 1985
  • K832826Aap Dosimetry Release or Basin SetsAmerican Hospital Supply Corp. · 1984
  • K830546Dosimetric ReleaseAmerican Hospital Supply Corp. · 1983
  • K822990Convertors Primary Wound Dressing IIAmerican Hospital Supply Corp. · 1983

Recent decisions in FME

The FME category page

  • K880385Kimberly-Clark Professional JacketKimberly-Clark Corp. · 1988
  • K770476Exam GownGeneral Medical Co. · 1977
  • K760954Crowntex Exam. Cape & GownGraham Manufacturing Co. · 1976
  • K760360Shirt, Mitten Cuff InfantPrecept, Inc. · 1976

https://510kreport.com/device/K811915 · printed Nov 6, 2026

Cite this page

510(k) Report. “K811915: Monitor/Vital Signs Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K811915

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