510(k) Report

510(k) · Cleared

Cleared

Insemi-Cath II

K954398510(k) TraditionalCleared Dec 19, 199590-day reviewClass II21 CFR 884.5250

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

Cook Urological, Inc. · MFD Cannula, Intrauterine Insemination

Cleared on Dec 19, 1995 after a 90-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
Dec 19, 1995
Review
90 days
Class
Class II
Product code
MFD
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared2023: 2 descendants cleared1995200020052010201520202025
  1. This deviceK954398 Insemi-Cath IICook Urological, Inc. · 1995
  2. Descendant · cites it directly · 2 of its ownK172321 Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine…Cook Incorporated · 2017
  3. Descendant · 2 generations on · 0 of its ownK231645 PherDal® At-Home Insemination KitPherdal Fertility Science, Inc. · 2023
  4. Descendant · 2 generations on · 0 of its ownK231203 Mosie Baby KitMosie Baby · 2023

Most influential descendants

Showing 3 of 3 · See all
  • K172321Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination CathetersCook Incorporated · 2017 · cites it directly2descendants
  • K231645PherDal® At-Home Insemination KitPherdal Fertility Science, Inc. · 2023 · 2 generations on0descendants
  • K231203Mosie Baby KitMosie Baby · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954398Insemi-Cath IICook Urological, Inc.1995—
+1K172321Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination…Cook Incorporated2017—
+2K231645PherDal® At-Home Insemination KitPherdal Fertility Science, Inc.2023—
+2K231203Mosie Baby KitMosie Baby2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
202320
FIG. 1 — Lineage of K954398, 1995–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 MFD? 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)

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

NumberDeviceApplicantDecidedDescendants
K172321Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination CathetersCook Incorporated20172

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, K172321 (Cook Incorporated, 2017) has gone furthest, with 2 descendants of its own.

How does its category compare?

All MFD devices

MFD Cannula, Intrauterine Insemination: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MFD

FDA has decided no MFD device since 2007.

Median 510(k) review, days · MFD

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

Recalls per year · MFD

No recall names MFD since 2007.

Adverse event reports per year · MFD

1in 2022

2007: 12011: 12019: 12022: 1
2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code MFD, 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—01
20080—00
20090—00
20100—00
20110—01
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—01
20200—00
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—

More from Cook Urological, Inc.

104 FDA decisions under this applicant name. See the company

  • K102141Cook Word Bartholin Gland Catheter (Final Trade Name Not Yet Determined)Cook Urological, Inc. · 2011
  • K0917673 Way Silicone Foley Balloon CatheterCook Urological, Inc. · 2009
  • K082939Cook Fetal Membrane Manipulator, Model -FMM-122400Cook Urological, Inc. · 2009
  • K082066Tao Brush I.U.M.C. Endometrial SamplerCook Urological, Inc. · 20081 recall
  • K082536Cook Wire GuidesCook Urological, Inc. · 20087 recalls

Recent decisions in MFD

The MFD category page

  • K021438Insemination Catheter, Model 320301Labotect Labor-Technik Gottingen · 2002
  • K012935Thecurve, Item 507Select Medical Systems, Inc. · 2001
  • K984306`the Inseminator' (Proposed)Wallach Surgical Devices, Inc. · 1999
  • K982630Medworks Visualization Insemination CatheterMedworks Corp. · 1999
  • K982628Medworks Insemination CatheterMedworks Corp. · 1998

https://510kreport.com/device/K954398 · printed Nov 6, 2026

Cite this page

510(k) Report. “K954398: Insemi-Cath II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954398

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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