510(k) Report

510(k) · Decided

Decided

Cell Collecting Brush

K924908510(k) TraditionalDecided Apr 13, 1993195-day reviewClass II21 CFR 884.4530

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

Anderson Winn Paper Co. · HHT Spatula, Cervical, Cytological

Cleared on Apr 13, 1993 after a 195-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Apr 13, 1993
Review
195 days
Class
Class II
Product code
HHT
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared1990200020102020
  1. This deviceK924908 Cell Collecting BrushAnderson Winn Paper Co. · 1993
  2. Descendant · cites it directly · 0 of its ownK111681 HistobrushPuritan Medical Products Company, LLC · 2012

Most influential descendants

Showing 1 of 1 · See all
  • K111681HistobrushPuritan Medical Products Company, LLC · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K924908Cell Collecting BrushAnderson Winn Paper Co.1993—
+1K111681HistobrushPuritan Medical Products Company, LLC2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
FIG. 1 — Lineage of K924908, 1993–2012Source: FDA 510(k) summaries, read by 510(k) Report · 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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  • 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K111681HistobrushPuritan Medical Products Company, LLC20120

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.

What does this lineage say?

  • Of its descendants, K111681 (Puritan Medical Products Company, LLC, 2012) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HHT devices

HHT Spatula, Cervical, Cytological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HHT

1in 2019

2007: 12008: 22009: 12012: 12015: 12017: 12019: 1
2007high 2 (2008) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HHT

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

Recalls per year · HHT

No recall names HHT since 2007.

Adverse event reports per year · HHT

1in 2025

2007: 22008: 32009: 12010: 12011: 12014: 12016: 62017: 12018: 12019: 32020: 32023: 52024: 12025: 1
2007high 6 (2016) · low 0 (2012)2025

MAUDE reports naming product code HHT, 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
20071—02
20082—03
20091—01
20100—01
20110—01
20121—00
20130—00
20140—01
20151—00
20160—06
20171—01
20180—01
20191—03
20200—03
20210—00
20220—00
20230—05
20240—01
20250—01
20260—0—
Cite this page

510(k) Report. “K924908: Cell Collecting Brush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K924908

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