510(k) Report

510(k) · Cleared

Cleared

Insemination Catheter, Model 320301

K021438510(k) AbbreviatedCleared Jul 16, 200271-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

Labotect Labor-Technik Gottingen · MFD Cannula, Intrauterine Insemination

Cleared on Jul 16, 2002 as substantially equivalent to K910577 (Marlo Surgical Technology, 1991) and 3 other predicates after a 71-day review. Its family tree reaches back 3 generations to 1991.

Decided
Jul 16, 2002
Review
71 days
Class
Class II
Product code
MFD
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K910577 (1991). 5 ancestors in all, the oldest K884696 (1989). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1992: 1 other ancestor1989: 1 other ancestorK910577 · Edwards-Wallace Bourne Hall Catheter · Marlo Surgical Technology · 1991K972823 · Mini-Embryon Intra Uterine Insemination Catheter · A & A Medical, Inc. · 1997K982628 · Medworks Insemination Catheter · Medworks Corp. · 19981985199019952000
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor K982628 · Medworks Insemination Catheter · Medworks Corp. · 1998K972823 · Mini-Embryon Intra Uterine Insemination Catheter · A & A Medical, Inc. · 1997K910577 · Edwards-Wallace Bourne Hall Catheter · Marlo Surgical Technology · 19910
  1. Root · 3 generations backK910577 Edwards-Wallace Bourne Hall CatheterMarlo Surgical Technology · 1991
  2. 2 generations backK972823 Mini-Embryon Intra Uterine Insemination CatheterA & A Medical, Inc. · 1997
  3. 1 generation backK982628 Medworks Insemination CatheterMedworks Corp. · 1998
  4. This deviceK021438 Insemination Catheter, Model 320301Labotect Labor-Technik Gottingen · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K910577Edwards-Wallace Bourne Hall CatheterMarlo Surgical Technology1991—
−2K972823Mini-Embryon Intra Uterine Insemination CatheterA & A Medical, Inc.1997—
−1K982628Medworks Insemination CatheterMedworks Corp.1998—
0 (this device)K021438Insemination Catheter, Model 320301Labotect Labor-Technik Gottingen2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199210
FIG. 1 — Lineage of K021438, 1991–2002Source: 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), 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? (5)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K910577Edwards-Wallace Bourne Hall Catheter
Summary page 1
…emination Catheter Proposed Classification Name: Assisted Reproduction Catheters Class II 85 MQF Edwards-Wallace Bourne-Hall (k9 10577) Marlow-Surgical Embryon Intra-uterine Insemination Catheters (k380061) Rocket Medical Mini-Embryon Intra Uterine hsemination C…
Marlo Surgical Technology1991—
Kept off the family treeK830061FDA’s K830061 is Thayer-Martin, Modified
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
bioMerieux, Inc.1983—
*K972823Mini-Embryon Intra Uterine Insemination Catheter
Summary page 1
…s-Wallace Bourne-Hall (k9 10577) Marlow-Surgical Embryon Intra-uterine Insemination Catheters (k380061) Rocket Medical Mini-Embryon Intra Uterine hsemination Catheter (k972823) A&A Medical, Inc. MedWorks Insemination Catheter (k982628) MedWorks Corp. Jansen-Anderson Insemination Set (k914150) Cook OBfGy…
A & A Medical, Inc.1997—
*K982628Medworks Insemination Catheter
Summary page 1
…ntra-uterine Insemination Catheters (k380061) Rocket Medical Mini-Embryon Intra Uterine hsemination Catheter (k972823) A&A Medical, Inc. MedWorks Insemination Catheter (k982628) MedWorks Corp. Jansen-Anderson Insemination Set (k914150) Cook OBfGyn…
Medworks Corp.1998—
*K914150Jansen-Anderson Insemination Set
Summary page 1
…l Mini-Embryon Intra Uterine hsemination Catheter (k972823) A&A Medical, Inc. MedWorks Insemination Catheter (k982628) MedWorks Corp. Jansen-Anderson Insemination Set (k914150) Cook OBfGyn . Device description and intended use:…
Cook Ob/Gyn1992—

Also cleared against K910577: 1 other device →

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?

  • The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
  • None of the 5 ancestors has a recall.
  • 1 other device also cites its predicate K910577.

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—

What is it indicated for?

The catheter is used for intrauterine insemination.

Indications for use as stated in the FDA summary.

Also cleared against K910577

1 other device cites the same predicate.

  • K972823Mini-Embryon Intra Uterine Insemination CatheterA & A Medical, Inc. · 1997

More from Labotect Labor-Technik Gottingen

3 FDA decisions under this applicant name. See the company

  • K003056Ovarial Biopsy Set 324102-324108; Ovarial Biopsy Set 324200-324202; Ovarial Biopsy Needle 32218Labotect Labor-Technik Gottingen · 2000
  • K000950Embryo Transfer Catheter Set, Model 320200 and 320201Labotect Labor-Technik Gottingen · 2000

Recent decisions in MFD

The MFD category page

  • 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
  • K980061Embryon Intrauterine Insemination Catheter, Emryon Soft Intrauterine Insemination Catheter, Stylet for…Rocket Medical Plc · 1998

https://510kreport.com/device/K021438 · printed Nov 5, 2026

Cite this page

510(k) Report. “K021438: Insemination Catheter, Model 320301.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021438

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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