510(k) Report

510(k) · Cleared

Cleared

Endobrush (TM) Device; Omnibrush

K897070510(k) TraditionalCleared Sep 10, 1990262-day reviewClass II21 CFR 884.1100

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

Intl. Cytobrush, Inc. · HFE Brush, Endometrial

Cleared on Sep 10, 1990 after a 262-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 10, 1990
Review
262 days
Class
Class II
Product code
HFE
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K897070Source: 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 HFE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HFE device

  1. #1 K240595 Utepreva Endometrial Sampler (UP01)score 8.4 · 3 generations · no Class I recall
Get a 510(k) Report

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 HFE devices

HFE Brush, Endometrial: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HFE

1in 2024

2008: 12012: 12017: 12024: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HFE

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

Recalls per year · HFE

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · HFE

1in 2016

2009: 12012: 12016: 1
2007high 1 (2009) · low 0 (2007)2025

MAUDE reports naming product code HFE, 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
20081—00
20090—11
20100—00
20110—00
20121—01
20130—00
20140—00
20150—00
20160—01
20171—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20241—00
20250—00
20260—0—

More from Intl. Cytobrush, Inc.

4 FDA decisions under this applicant name. See the company

  • K895675Pap Smear TrayIntl. Cytobrush, Inc. · 1989
  • K862322Chlamydia Kit, STD KitIntl. Cytobrush, Inc. · 1986
  • K861389Pap Smear KitIntl. Cytobrush, Inc. · 1986

Recent decisions in HFE

The HFE category page

  • K240595Utepreva Endometrial Sampler (UP01)Utepreva, LLC · 2024
  • K170603Tao Brush I.U.M.C. Endometrial SamplerCook Incorporated · 2017
  • K112763Matrixbrush Endometrial SamplerPost Oak Innovations, Inc. · 2012
  • K082066Tao Brush I.U.M.C. Endometrial SamplerCook Urological, Inc. · 20081 recall
  • K941298Iumc Endometrial SamplerCook Ob/Gyn · 19951 recall

https://510kreport.com/device/K897070 · printed Nov 4, 2026

Cite this page

510(k) Report. “K897070: Endobrush (TM) Device; Omnibrush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K897070

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