510(k) Report

510(k) · Cleared

Cleared

Cleaning Brush

K874239510(k) TraditionalCleared Dec 29, 198774-day reviewClass I21 CFR 876.1500

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

Endovations · MNL Accessories, Cleaning Brushes, For Endoscope

Cleared on Dec 29, 1987 after a 74-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 29, 1987
Review
74 days
Class
Class I
Product code
MNL
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K874239Source: 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 MNL? 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 MNL devices

MNL Accessories, Cleaning Brushes, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNL

FDA has decided no MNL device since 2007.

Median 510(k) review, days · MNL

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

Recalls per year · MNL

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

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

Adverse event reports per year · MNL

141in 2025

2008: 32009: 62010: 62011: 62012: 62014: 62015: 102016: 162017: 182018: 462019: 472020: 282021: 682022: 602023: 652024: 662025: 141
2007high 141 (2025) · low 0 (2007)2025

MAUDE reports naming product code MNL, 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—03
20090—06
20100—06
20110—06
20120—06
20130—00
20140—06
20150—010
20160—016
20170—018
20180—146
20190—047
20200—028
20210—068
20220—060
20230—065
20240—066
20250—0141
20260—0—

More from Endovations

37 FDA decisions under this applicant name. See the company

  • K955413Endovations Triple Lumen Balloon Dilatation CatheterEndovations · 1996
  • K942110Inject-SnareEndovations · 1994
  • K934315Endovations (R) .035 Pre-Cut PapillatomeEndovations · 1994
  • K9138412 Lumen Endos Retro Cholangiopancrea Injec CathEndovations · 1991
  • K9138705MM MicroscissorsEndovations · 1991

Recent decisions in MNL

The MNL category page

  • K950689UCBCox Medical Ent., Inc. · 1995
  • K946293Mill-Rose Scope Cleaning BrushMill-Rose Laboratory · 1995
  • K892218Endo-SpongeEndovations · 1989

https://510kreport.com/device/K874239 · printed Nov 6, 2026

Cite this page

510(k) Report. “K874239: Cleaning Brush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K874239

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