510(k) Report

510(k) · Cleared

Cleared

Pap Smear Kit

K861389510(k) TraditionalCleared May 2, 198618-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

Intl. Cytobrush, Inc. · HHT Spatula, Cervical, Cytological

Cleared on May 2, 1986 after an 18-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
May 2, 1986
Review
18 days
Class
Class II
Product code
HHT
Recalls
None
Predicates
0

3 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2019: 1 descendant cleared2017: 1 descendant cleared2007: 1 descendant cleared1990200020102020
  1. This deviceK861389 Pap Smear KitIntl. Cytobrush, Inc. · 1986
  2. Descendant · cites it directly · 0 of its ownK182049 exCellerator Cervical Collection DeviceExcell Company, LLC · 2019
  3. Descendant · cites it directly · 0 of its ownK153128 Kolplast Cervical Sample Collection KitKolplast CI SA · 2017
  4. Descendant · cites it directly · 0 of its ownK062433 Diamics Cercol Cervical Sample Collector SystemDiamics, Inc. · 2007

Most influential descendants

Showing 3 of 3 · See all
  • K182049exCellerator Cervical Collection DeviceExcell Company, LLC · 2019 · cites it directly0descendants
  • K153128Kolplast Cervical Sample Collection KitKolplast CI SA · 2017 · cites it directly0descendants
  • K062433Diamics Cercol Cervical Sample Collector SystemDiamics, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K861389Pap Smear KitIntl. Cytobrush, Inc.1986—
+1K182049exCellerator Cervical Collection DeviceExcell Company, LLC2019—
+1K153128Kolplast Cervical Sample Collection KitKolplast CI SA2017—
+1K062433Diamics Cercol Cervical Sample Collector SystemDiamics, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201710
201910
FIG. 1 — Lineage of K861389, 1986–2019Source: 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.

Planning a device in HHT? 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? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K182049exCellerator Cervical Collection DeviceExcell Company, LLC20190
K153128Kolplast Cervical Sample Collection KitKolplast CI SA20170
K062433Diamics Cercol Cervical Sample Collector SystemDiamics, Inc.20070

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, K182049 (Excell Company, LLC, 2019) 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—

More from Intl. Cytobrush, Inc.

4 FDA decisions under this applicant name. See the company

  • K897070Endobrush (TM) Device; OmnibrushIntl. Cytobrush, Inc. · 1990
  • K895675Pap Smear TrayIntl. Cytobrush, Inc. · 1989
  • K862322Chlamydia Kit, STD KitIntl. Cytobrush, Inc. · 1986

Recent decisions in HHT

The HHT category page

  • K182049exCellerator Cervical Collection DeviceExcell Company, LLC · 2019
  • K153128Kolplast Cervical Sample Collection KitKolplast CI SA · 2017
  • K141057Disposable Cervical BrushNingbo Hls Medical Products Co., Ltd. · 2015
  • K111681HistobrushPuritan Medical Products Company, LLC · 2012
  • K083012PapconeOtto Bock Pur Life Science GmbH · 2009

https://510kreport.com/device/K861389 · printed Nov 4, 2026

Cite this page

510(k) Report. “K861389: Pap Smear Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K861389

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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