510(k) Report

510(k) · Cleared

Cleared

#491 Power Otolaryngoly CH/#498 Proced CTR & Acces

K910781510(k) TraditionalCleared May 15, 199179-day reviewClass I21 CFR 874.5300

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

Midmark Corp. · ETF Unit, Examining/Treatment, Ent

Cleared on May 15, 1991 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 15, 1991
Review
79 days
Class
Class I
Product code
ETF
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K910781Source: 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 ETF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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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 ETF devices

ETF Unit, Examining/Treatment, Ent: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ETF

FDA has decided no ETF device since 2007.

Median 510(k) review, days · ETF

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

Recalls per year · ETF

No recall names ETF since 2007.

Adverse event reports per year · ETF

1in 2021

2010: 22011: 12012: 12021: 1
2007high 2 (2010) · low 0 (2007)2025

MAUDE reports naming product code ETF, 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—02
20110—01
20120—01
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—01
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Midmark Corp.

31 FDA decisions under this applicant name. See the company

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  • K023348Midmark M9 Ultraclave Steam SterilizerMidmark Corp. · 2003
  • K003090Midmark Procenter Instrument Delivery SystemMidmark Corp. · 2000

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The ETF category page

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https://510kreport.com/device/K910781 · printed Nov 3, 2026

Cite this page

510(k) Report. “K910781: #491 Power Otolaryngoly CH/#498 Proced CTR & Acces.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K910781

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