510(k) Report

510(k) · Cleared

Cleared

Endoscopic Tray

K771049510(k) TraditionalCleared Sep 12, 197794-day reviewClass I21 CFR 874.4420

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. · MMO Tray, Surgical, Ent

Cleared on Sep 12, 1977 after a 94-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 12, 1977
Review
94 days
Class
Class I
Product code
MMO
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K771049Source: 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 MMO? 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 MMO devices

MMO Tray, Surgical, Ent: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MMO

FDA has decided no MMO device since 2007.

Median 510(k) review, days · MMO

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

Recalls per year · MMO

1in 2024

2022: 12024: 12026 (partial year): 1
2007high 1 (2022) · low 0 (2007)2026

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

Adverse event reports per year · MMO

2in 2023

2018: 22019: 72021: 22023: 2
2007high 7 (2019) · low 0 (2007)2025

MAUDE reports naming product code MMO, 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—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—02
20190—07
20200—00
20210—02
20220—10
20230—02
20240—10
20250—00
20260—1—

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

https://510kreport.com/device/K771049 · printed Nov 6, 2026

Cite this page

510(k) Report. “K771049: Endoscopic Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K771049

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