510(k) Report

510(k) · Cleared

Cleared

Cytoprep

K983181510(k) TraditionalCleared Nov 16, 199866-day reviewClass II21 CFR 884.5070

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

Cytoprep Inc. Est. · HHI System, Abortion, Vacuum

Cleared on Nov 16, 1998 as substantially equivalent to K930955 (Rovers B.V., 1994) and 1 other predicate after a 66-day review. Its family tree reaches back 1 generation to 1994.

Decided
Nov 16, 1998
Review
66 days
Class
Class II
Product code
HHI
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K915844 (1994). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 1 other ancestorK915844 · Exact-Touch · Baal Assoc., Inc. · 1994199019921994199619982000
Other ancestors, by generation 1 generation back: 1 other ancestor K915844 · Exact-Touch · Baal Assoc., Inc. · 19940
  1. Root · 1 generation backK915844 Exact-TouchBaal Assoc., Inc. · 1994
  2. This deviceK983181 CytoprepCytoprep Inc. Est. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K915844Exact-TouchBaal Assoc., Inc.1994—
0 (this device)K983181CytoprepCytoprep Inc. Est.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
FIG. 1 — Lineage of K983181, 1994–1998Source: 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), the FDA summary (predicates and indications), 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? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K930955Cervex-Brush
Summary page 1
…® TRADE NAME: CYTOPREP® COMMON NAME;: Cervical Brush CLASSIFICATION NAME: Spatula, Cervical, Cytological (per 21 CFR 884.4530) CLAIMING EQUIVELANCE TO: Cervex-Brush® (K930955) and Exact Touch (K915844) DESCRIPTION OF cyrTOoOPREFPQ: CYTOPREP® consists of two parts, the handle and the head. The handle i…
Rovers B.V.1994—
*K915844Exact-Touch
Summary page 1
…OMMON NAME;: Cervical Brush CLASSIFICATION NAME: Spatula, Cervical, Cytological (per 21 CFR 884.4530) CLAIMING EQUIVELANCE TO: Cervex-Brush® (K930955) and Exact Touch (K915844) DESCRIPTION OF cyrTOoOPREFPQ: CYTOPREP® consists of two parts, the handle and the head. The handle is 214mm in length, cylindr…
Baal Assoc., Inc.1994—

Also cleared against K930955: 2 other devices →

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.

What does this lineage say?

  • None of the 2 ancestors has a recall.
  • 2 other devices also cite its predicate K930955.

How does its category compare?

All HHI devices

HHI System, Abortion, Vacuum: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HHI

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HHI

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

Recalls per year · HHI

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

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

Adverse event reports per year · HHI

3in 2024

2010: 22011: 12013: 22015: 42016: 12017: 62018: 52019: 62020: 32021: 32022: 62023: 12024: 3
2007high 6 (2017) · low 0 (2007)2025

MAUDE reports naming product code HHI, 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—00
20130—02
20140—00
20150—04
20160—01
20171—06
20180—05
20190—16
20200—03
20210—03
20220—06
20230—01
20240—03
20250—00
20260—0—

What is it indicated for?

The device is used to sample the cervix of patients for the purpose of obtaining ecto-cervical, endo-cervical and T-zone sample cells. These sample cells are used for the “PAP” test.

While the product is designed to be used in conjunction with liquid based cytology procedure (monolayer method), it can also be used in conjunction with the traditional “PAP” test procedure.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K930955

2 other devices cite the same predicate.

  • K083012PapconeOtto Bock Pur Life Science GmbH · 2009
  • K013258Inpath E2 CollectorMolecular Diagnostics · 2002

Recent decisions in HHI

The HHI category page

  • K171440Berkeley VC-10 Vacuum Curettage SystemGyrus Acmi · 20171 recall
  • K030935Berkeley V-10 Vacuum Curettage SystemAcmi Corporation · 20031 recall
  • K931205Medi Vac Specimen Collector and TransporterBaxter Healthcare Corp · 1994
  • K904160Cytosmear BrushBrooke Intl. · 1990
  • K900641Cannula, Suction UterineWilliams Specialty Products, Inc. · 1990

https://510kreport.com/device/K983181 · printed Nov 6, 2026

Cite this page

510(k) Report. “K983181: Cytoprep.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983181

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026