510(k) Report

510(k) · Cleared

Cleared

Sterile Surgical Scrub Brush

K874653510(k) TraditionalCleared Dec 30, 198747-day reviewClass I21 CFR 878.4800

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

Surgikos, Inc. · GEC Brush, Scrub, Operating-Room

Cleared on Dec 30, 1987 after a 47-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 30, 1987
Review
47 days
Class
Class I
Product code
GEC
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K874653Source: 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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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 GEC devices

GEC Brush, Scrub, Operating-Room: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEC

FDA has decided no GEC device since 2007.

Median 510(k) review, days · GEC

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

Recalls per year · GEC

No recall names GEC since 2007.

Adverse event reports per year · GEC

3in 2024

2009: 62010: 12011: 12012: 22014: 22015: 12017: 32018: 42020: 82021: 162022: 12023: 82024: 3
2007high 16 (2021) · low 0 (2007)2025

MAUDE reports naming product code GEC, 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—06
20100—01
20110—01
20120—02
20130—00
20140—02
20150—01
20160—00
20170—03
20180—04
20190—00
20200—08
20210—016
20220—01
20230—08
20240—03
20250—00
20260—0—

More from Surgikos, Inc.

56 FDA decisions under this applicant name. See the company

  • K875107Health Care Eye ProtectionSurgikos, Inc. · 1988
  • K861441Neutralon Surgical GlovesSurgikos, Inc. · 1986
  • K852870Barrier Surgical GownSurgikos, Inc. · 1985
  • K822535Cidex*Dialyzer Disinfecting SolutionSurgikos, Inc. · 1982
  • K820543Barrier Antimicrobial Incise DrapeSurgikos, Inc. · 1982

Recent decisions in GEC

The GEC category page

  • K971473Ivalon Instrument Wipe, Ivalon Knife Cleaning BlockM-Pact Worldwide Management Corp. · 1997
  • K960621Expandacell Instrument WipeShippert Medical Technologies Corp. · 1996
  • K900691Biodyne Instrument WipesBio-Dyne, Inc. · 1990
  • K896085Surgi-BrushSparta Surgical Corp. · 1989
  • K875033Sterile Scrubby Scrub BrushMedsurg Industries, Inc. · 1988

https://510kreport.com/device/K874653 · printed Nov 4, 2026

Cite this page

510(k) Report. “K874653: Sterile Surgical Scrub Brush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K874653

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