510(k) Report

510(k) · Cleared

Cleared

Edwards-Wallace Bourne Hall Catheter

K910577510(k) TraditionalCleared May 9, 199187-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

Marlo Surgical Technology · MFD Cannula, Intrauterine Insemination

Cleared on May 9, 1991 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.

Decided
May 9, 1991
Review
87 days
Class
Class II
Product code
MFD
Recalls
None
Predicates
0

5 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared2002: 1 descendant cleared1998: 1 descendant cleared1999: 2 descendants cleared1990200020102020
  1. This deviceK910577 Edwards-Wallace Bourne Hall CatheterMarlo Surgical Technology · 1991
  2. Descendant · cites it directly · 4 of its ownK972823 Mini-Embryon Intra Uterine Insemination CatheterA & A Medical, Inc. · 1997
  3. Descendant · 2 generations on · 1 of its ownK982628 Medworks Insemination CatheterMedworks Corp. · 1998
  4. Descendant · cites it directly · 0 of its ownK021438 Insemination Catheter, Model 320301Labotect Labor-Technik Gottingen · 2002
  5. Descendant · 2 generations on · 0 of its ownK984306 `the Inseminator' (Proposed)Wallach Surgical Devices, Inc. · 1999
  6. Descendant · 2 generations on · 0 of its ownK982630 Medworks Visualization Insemination CatheterMedworks Corp. · 1999

Most influential descendants

Showing 5 of 5 · See all
  • K972823Mini-Embryon Intra Uterine Insemination CatheterA & A Medical, Inc. · 1997 · cites it directly4descendants
  • K982628Medworks Insemination CatheterMedworks Corp. · 1998 · 2 generations on1descendant
  • K021438Insemination Catheter, Model 320301Labotect Labor-Technik Gottingen · 2002 · cites it directly0descendants
  • K984306`the Inseminator' (Proposed)Wallach Surgical Devices, Inc. · 1999 · 2 generations on0descendants
  • K982630Medworks Visualization Insemination CatheterMedworks Corp. · 1999 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K910577Edwards-Wallace Bourne Hall CatheterMarlo Surgical Technology1991—
+1K972823Mini-Embryon Intra Uterine Insemination CatheterA & A Medical, Inc.1997—
+2K982628Medworks Insemination CatheterMedworks Corp.1998—
+1K021438Insemination Catheter, Model 320301Labotect Labor-Technik Gottingen2002—
+2K984306`the Inseminator' (Proposed)Wallach Surgical Devices, Inc.1999—
+2K982630Medworks Visualization Insemination CatheterMedworks Corp.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
199920
200210
FIG. 1 — Lineage of K910577, 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MFD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (5)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K972823Mini-Embryon Intra Uterine Insemination CatheterA & A Medical, Inc.19974
K021438Insemination Catheter, Model 320301Labotect Labor-Technik Gottingen20020

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, K972823 (A & A Medical, Inc., 1997) has gone furthest, with 4 descendants 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 Marlo Surgical Technology

28 FDA decisions under this applicant name. See the company

  • K960810Balloon Cannula 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MMMarlo Surgical Technology · 1996
  • K962273Malleable Stylet 18 CM ME1816ST, 23 CM ME1816NSTMarlo Surgical Technology · 1996
  • K924611Irrigation Pump and Tubing SetMarlo Surgical Technology · 1994
  • K932634NU-Tip (TM) Forceps:Graspers/Dissectors/SuturesMarlo Surgical Technology · 1994
  • K932832Primus Insulated ForcepsMarlo Surgical Technology · 1994

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/K910577 · printed Nov 6, 2026

Cite this page

510(k) Report. “K910577: Edwards-Wallace Bourne Hall Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910577

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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