510(k) Report

510(k) · Cleared

Cleared

`the Inseminator' (Proposed)

K984306510(k) TraditionalCleared Mar 1, 199989-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

Wallach Surgical Devices, Inc. · MFD Cannula, Intrauterine Insemination

Cleared on Mar 1, 1999 as substantially equivalent to K972245 (A & A Medical, Inc., 1997) and 4 other predicates after an 89-day review. Its family tree reaches back 2 generations to 1991.

Decided
Mar 1, 1999
Review
89 days
Class
Class II
Product code
MFD
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K910577 (1991). 6 ancestors in all, the oldest K910317 (1991). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 2 other ancestors1994: 1 other ancestor1991: 1 other ancestorK910577 · Edwards-Wallace Bourne Hall Catheter · Marlo Surgical Technology · 1991K972823 · Mini-Embryon Intra Uterine Insemination Catheter · A & A Medical, Inc. · 1997199019921994199619982000
Other ancestors, by generation 1 generation back: 4 other ancestors K972823 · Mini-Embryon Intra Uterine Insemination Catheter · A & A Medical, Inc. · 1997K910577 · Edwards-Wallace Bourne Hall Catheter · Marlo Surgical Technology · 19910
  1. Root · 2 generations backK910577 Edwards-Wallace Bourne Hall CatheterMarlo Surgical Technology · 1991
  2. 1 generation backK972823 Mini-Embryon Intra Uterine Insemination CatheterA & A Medical, Inc. · 1997
  3. This deviceK984306 `the Inseminator' (Proposed)Wallach Surgical Devices, Inc. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K910577Edwards-Wallace Bourne Hall CatheterMarlo Surgical Technology1991—
−1K972823Mini-Embryon Intra Uterine Insemination CatheterA & A Medical, Inc.1997—
0 (this device)K984306`the Inseminator' (Proposed)Wallach Surgical Devices, Inc.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199410
199720
FIG. 1 — Lineage of K984306, 1991–1999Source: 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.

TypeNumberDeviceApplicantDecidedRecalls
*K972245Tom Cat F.L., Tom Cat S.L.
Summary page 1
…ode 85 MFD. Predicate Devices to which we are claiming substantial equivalence: AW = CooperSurgical. Product Description: TomCat Intrauterine Insemination Catheter (K972245), A & A Medical. Mini-Embryon Intrauterine Insemination Catheter (K972823), A & A Medical. Insemi-Cath (K931630), Cook OB/GYN. W…
A & A Medical, Inc.1997—
*K972823Mini-Embryon Intra Uterine Insemination Catheter
Summary page 1
…lence: AW = CooperSurgical. Product Description: TomCat Intrauterine Insemination Catheter (K972245), A & A Medical. Mini-Embryon Intrauterine Insemination Catheter (K972823), A & A Medical. Insemi-Cath (K931630), Cook OB/GYN. Wallace Artificial Insemination Catheter (K964848), Marlow Surgical Technol…
A & A Medical, Inc.1997—
*K931630Insemi-Cath
Summary page 1
…Description: TomCat Intrauterine Insemination Catheter (K972245), A & A Medical. Mini-Embryon Intrauterine Insemination Catheter (K972823), A & A Medical. Insemi-Cath (K931630), Cook OB/GYN. Wallace Artificial Insemination Catheter (K964848), Marlow Surgical Technologies. Uni-Sem™ Intrauterine Cannula f…
Cook Ob/Gyn1994—
*K964848Wallace Artificial Insemination Catheter - 8CM/18CM
Summary page 1
…, A & A Medical. Mini-Embryon Intrauterine Insemination Catheter (K972823), A & A Medical. Insemi-Cath (K931630), Cook OB/GYN. Wallace Artificial Insemination Catheter (K964848), Marlow Surgical Technologies. Uni-Sem™ Intrauterine Cannula for Artificial Insemination (K910317), Unimar / The malleable cath…
Marlow Surgical Technologies, Inc.19971
*K910317Uni-Sem (TM)
Summary page 1
…ath (K931630), Cook OB/GYN. Wallace Artificial Insemination Catheter (K964848), Marlow Surgical Technologies. Uni-Sem™ Intrauterine Cannula for Artificial Insemination (K910317), Unimar / The malleable catheter of Wallach’s ‘Inseminator” includes the fine, smoothed tip, with a flared proximal end. Insemi…
Unimar, Inc.1991—

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 8 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
  • 1 of the 6 ancestors has a recall of any class.

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 ‘Inseminator’ is used for intrauterine artificial insemination procedures utilizing washed spermatozoa or semen.

The “Inseminator’ is not intended for intrafallopian tube or in vitro-fertilization (IVF) procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Wallach Surgical Devices, Inc.

27 FDA decisions under this applicant name. See the company

  • K021224Endocervical Block NeedleWallach Surgical Devices, Inc. · 2002
  • K020711Wallach Loop ElectrodeWallach Surgical Devices, Inc. · 20021 recall
  • K000768Wallach Quantum 500 Electrosurgical GeneratorWallach Surgical Devices, Inc. · 2000
  • K992736Wallach's Ultimate Reusable, Plastic Vaginal SpeculumWallach Surgical Devices, Inc. · 1999
  • K991669PMS 750 FingerswitchWallach Surgical Devices, Inc. · 1999

Recent decisions in MFD

The MFD category page

  • K021438Insemination Catheter, Model 320301Labotect Labor-Technik Gottingen · 2002
  • K012935Thecurve, Item 507Select Medical Systems, Inc. · 2001
  • 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/K984306 · printed Nov 4, 2026

Cite this page

510(k) Report. “K984306: `the Inseminator' (Proposed).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984306

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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