510(k) Report

510(k) · Cleared

Cleared

Medworks Visualization Insemination Catheter

K982630510(k) TraditionalCleared Jan 14, 1999170-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

Medworks Corp. · MFD Cannula, Intrauterine Insemination

Cleared on Jan 14, 1999 as substantially equivalent to K884696 (Laboratoire Ccd C/O Washington Regulatory Services, 1989) and 7 other predicates after a 170-day review. Its family tree reaches back 2 generations to 1991.

Decided
Jan 14, 1999
Review
170 days
Class
Class II
Product code
MFD
Recalls
None
Predicates
8

Its longest line of descent runs back 2 generations to K910577 (1991). 9 ancestors in all, the oldest K884696 (1989). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestor1997: 1 other ancestor1996: 2 other ancestors1992: 1 other ancestor1990: 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. · 19971985199019952000
Other ancestors, by generation 1 generation back: 7 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 deviceK982630 Medworks Visualization Insemination CatheterMedworks Corp. · 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)K982630Medworks Visualization Insemination CatheterMedworks Corp.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199010
199210
199620
199710
199810
FIG. 1 — Lineage of K982630, 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? (8)

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
*K884696Resubmitted Artificial Insemination Instrument Set
Summary page 1
…f the Federal Food, Drug, and Cosmetic Act, the device classification is Class II. Predicate Devices: Roseff’s Double Lumen Standard Intrauterine Insemination Catheter (K884696) Fertility Technologies, Inc. Standard Intrauterine Insemination Catheter (K884696) CCD International Mini-Embryon Intra Uterin…
Laboratoire Ccd C/O Washington Regulatory Services1989—
*K972823Mini-Embryon Intra Uterine Insemination Catheter
Summary page 1
…theter (K884696) Fertility Technologies, Inc. Standard Intrauterine Insemination Catheter (K884696) CCD International Mini-Embryon Intra Uterine Insemination Catheter (K972823) A&A Medical, Inc. Jansen-Anderson Insemination Set (K914150) Cook Ob/Gyn Centurion Vaginal Speculum (K897100) Tri-State Hospit…
A & A Medical, Inc.1997—
*K914150Jansen-Anderson Insemination Set
Summary page 1
…terine Insemination Catheter (K884696) CCD International Mini-Embryon Intra Uterine Insemination Catheter (K972823) A&A Medical, Inc. Jansen-Anderson Insemination Set (K914150) Cook Ob/Gyn Centurion Vaginal Speculum (K897100) Tri-State Hospital Supply Galileo Disposable Endoscope (K981928) Galileo Elec…
Cook Ob/Gyn1992—
*K897100Centurion Vaginal Speculum
Summary page 1
…tional Mini-Embryon Intra Uterine Insemination Catheter (K972823) A&A Medical, Inc. Jansen-Anderson Insemination Set (K914150) Cook Ob/Gyn Centurion Vaginal Speculum (K897100) Tri-State Hospital Supply Galileo Disposable Endoscope (K981928) Galileo Electro-Optics Corp. Imagyn MicroSpan Insemination Sy…
Tri-State Hospital Supply Corp.1990—
*K981928Galileo Disposable Endoscopes
Cleared while this submission was under review
Summary page 1
…A&A Medical, Inc. Jansen-Anderson Insemination Set (K914150) Cook Ob/Gyn Centurion Vaginal Speculum (K897100) Tri-State Hospital Supply Galileo Disposable Endoscope (K981928) Galileo Electro-Optics Corp. Imagyn MicroSpan Insemination System (970750), MicroSpan Hysteroscope Sheath (K961506) and MicroSp…
Galileo Electro-Optics Corp.1998—
*K970750Microspan Insemination System
Summary page 1
…enturion Vaginal Speculum (K897100) Tri-State Hospital Supply Galileo Disposable Endoscope (K981928) Galileo Electro-Optics Corp. Imagyn MicroSpan Insemination System (970750), MicroSpan Hysteroscope Sheath (K961506) and MicroSpan Hysteroscope (K961688) Imagyn Medical, Inc. Product Description: Malleab…
Imagyn Medical, Inc.1997—
*K961506Microspan Hysteroscope Sheath
Summary page 1
…State Hospital Supply Galileo Disposable Endoscope (K981928) Galileo Electro-Optics Corp. Imagyn MicroSpan Insemination System (970750), MicroSpan Hysteroscope Sheath (K961506) and MicroSpan Hysteroscope (K961688) Imagyn Medical, Inc. Product Description: Malleable catheter with distal side ports and a…
Imagyn Medical, Inc.1996—
*K961688Microspan Hysteroscope
Summary page 1
…able Endoscope (K981928) Galileo Electro-Optics Corp. Imagyn MicroSpan Insemination System (970750), MicroSpan Hysteroscope Sheath (K961506) and MicroSpan Hysteroscope (K961688) Imagyn Medical, Inc. Product Description: Malleable catheter with distal side ports and a lumen which can accommodate a fiberop…
Imagyn Medical, Inc.1996—

Also cleared against K884696: 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 8 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
  • None of the 9 ancestors has a recall.
  • 1 other device also cites its predicate K884696.

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?

For use in intrauterine artificial insemination procedures using washed spermatozoa or semen.

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

Also cleared against K884696

1 other device cites the same predicate.

  • K982628Medworks Insemination CatheterMedworks Corp. · 1998

More from Medworks Corp.

3 FDA decisions under this applicant name. See the company

  • K982628Medworks Insemination CatheterMedworks Corp. · 1998
  • K982626Urethropexy Suture Placement Kit Model Numbers UM-300, MW-100, Mini-Laparotomy MMK Kit Model UM-250…Medworks Corp. · 1998

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
  • K982628Medworks Insemination CatheterMedworks Corp. · 1998
  • K980061Embryon Intrauterine Insemination Catheter, Emryon Soft Intrauterine Insemination Catheter, Stylet for…Rocket Medical Plc · 1998

https://510kreport.com/device/K982630 · printed Nov 5, 2026

Cite this page

510(k) Report. “K982630: Medworks Visualization Insemination Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982630

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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