510(k) Report

510(k) · Cleared

Cleared

Coaxial Catheter Set

K902694510(k) TraditionalCleared Aug 28, 199070-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 Ob/Gyn · HDR Cap, Cervical

Cleared on Aug 28, 1990 after a 70-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
Aug 28, 1990
Review
70 days
Class
Class II
Product code
HDR
Recalls
None
Predicates
0

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

Descendants, by year cleared 2017: 1 descendant cleared2023: 2 descendants cleared1990200020102020
  1. This deviceK902694 Coaxial Catheter SetCook Ob/Gyn · 1990
  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)K902694Coaxial Catheter SetCook Ob/Gyn1990—
+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 K902694, 1990–2023Source: 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 HDR? 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 HDR device

  1. #1 K242031 Béa Applicator (BAP-GB-01)score 9.4 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
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? (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 HDR devices

HDR Cap, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HDR

1in 2025

2023: 12025: 1
2007high 1 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HDR

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

Recalls per year · HDR

No recall names HDR since 2007.

Adverse event reports per year · HDR

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2025

MAUDE reports naming product code HDR, 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—00
20110—00
20120—00
20130—00
20140—01
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20231—00
20240—00
20251—00
20260—0—

More from Cook Ob/Gyn

43 FDA decisions under this applicant name. See the company

  • K062438Bakri Postpartum Balloon, Model J-Sos-100500Cook Ob/Gyn · 2006
  • K030441Sydney Ivf Blastocyst Cryopreservation Kit and Sydney Ivf Blastocyst Thaw KitCook Ob/Gyn · 2003
  • K023850Sydney Ivf Embryo Biopsy MediumCook Ob/Gyn · 2003
  • K013597Tamponade Uterine Balloon Catheter SetCook Ob/Gyn · 2002
  • K002385Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf Fertilization Medium, Cook Ivf…Cook Ob/Gyn · 2000

Recent decisions in HDR

The HDR category page

  • K242031Béa Applicator (BAP-GB-01)Stepone Fertility Ltd (T/A Béa Fertility) · 2025
  • K222969FERTI-LILY Conception CupRosesta Medical BV · 2023
  • K993953Oves Cervical CapVeos, Ltd. · 2000
  • K945131Imagyn Intrauterine Insemination DeviceImagyn Medical, Inc. · 1995
  • K950714Cook Insemination CupCook Urological, Inc. · 1995

https://510kreport.com/device/K902694 · printed Nov 6, 2026

Cite this page

510(k) Report. “K902694: Coaxial Catheter Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K902694

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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