510(k) Report

510(k) · Cleared

Cleared

Jansen-Anderson Insemination Set

K914150510(k) TraditionalCleared Sep 2, 1992352-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 · MFD Cannula, Intrauterine Insemination

Cleared on Sep 2, 1992 after a 352-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Sep 2, 1992
Review
352 days
Class
Class II
Product code
MFD
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared1998: 1 descendant cleared1999: 1 descendant cleared1990200020102020
  1. This deviceK914150 Jansen-Anderson Insemination SetCook Ob/Gyn · 1992
  2. Descendant · cites it directly · 1 of its ownK982628 Medworks Insemination CatheterMedworks Corp. · 1998
  3. Descendant · cites it directly · 0 of its ownK021438 Insemination Catheter, Model 320301Labotect Labor-Technik Gottingen · 2002
  4. Descendant · cites it directly · 0 of its ownK982630 Medworks Visualization Insemination CatheterMedworks Corp. · 1999

Most influential descendants

Showing 3 of 3 · See all
  • K982628Medworks Insemination CatheterMedworks Corp. · 1998 · cites it directly1descendant
  • K021438Insemination Catheter, Model 320301Labotect Labor-Technik Gottingen · 2002 · cites it directly0descendants
  • K982630Medworks Visualization Insemination CatheterMedworks Corp. · 1999 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K914150Jansen-Anderson Insemination SetCook Ob/Gyn1992—
+1K982628Medworks Insemination CatheterMedworks Corp.1998—
+1K021438Insemination Catheter, Model 320301Labotect Labor-Technik Gottingen2002—
+1K982630Medworks Visualization Insemination CatheterMedworks Corp.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200210
FIG. 1 — Lineage of K914150, 1992–2002Source: 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.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, 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
K982628Medworks Insemination CatheterMedworks Corp.19981
K021438Insemination Catheter, Model 320301Labotect Labor-Technik Gottingen20020
K982630Medworks Visualization Insemination CatheterMedworks Corp.19990

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, K982628 (Medworks Corp., 1998) has gone furthest, with 1 descendant 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 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 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/K914150 · printed Nov 6, 2026

Cite this page

510(k) Report. “K914150: Jansen-Anderson Insemination Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914150

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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