510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Wallace Catheters-18CM, Model 1816; 23CM, Model 1816N; 23CM, Model 2316

K990350510(k) TraditionalCleared Jul 26, 1999171-day reviewClass II21 CFR 884.6110Recalls 6

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

CooperSurgical, Inc. · MQF Catheter, Assisted Reproduction

Cleared on Jul 26, 1999 after a 171-day review. The FDA summary names no predicate by number. 8 later devices descend from it. It has been recalled 6 times.

Decided
Jul 26, 1999
Review
171 days
Class
Class II
Product code
MQF
Recalls
6
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared2006: 1 descendant cleared2003: 1 descendant cleared2017: 3 descendants cleared2025: 1 descendant cleared2026: 1 descendant cleared1995200020052010201520202025
  1. This deviceK990350 Wallace Catheters-18CM, Model 1816; 23CM, Model 1816N; 23CM, Model…CooperSurgical, Inc. · 1999
  2. Descendant · cites it directly · 5 of its ownK033084 Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer…Portex, Ltd. · 2003 · Recalled
  3. Descendant · 2 generations on · 2 of its ownK162878 Kitazato ET CathetersKitazato Corporation · 2017
  4. Descendant · cites it directly · 1 of its ownK023379 Coopersurgical Embryo Transfer Catheter, Coopersurgical Assisted…Cooper Surgical · 2002
  5. Descendant · 3 generations on · 0 of its ownK253354 Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C…Guangzhou Hehong Biotech Co., Ltd. · 2026
  6. Descendant · 3 generations on · 0 of its ownK243373 Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo…Vitrolife Sweden AB · 2025

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12006: 12017: 32025: 12026: 1
2002high 3 (2017) · low 0 (2004)2026

Most influential descendants

Showing 5 of 8 · See all
  • K033084Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer CatheterPortex, Ltd. · 2003 · cites it directly5descendants
  • K162878Kitazato ET CathetersKitazato Corporation · 2017 · 2 generations on2descendants
  • K023379Coopersurgical Embryo Transfer Catheter, Coopersurgical Assisted Reproduction CatheterCooper Surgical · 2002 · cites it directly1descendant
  • K253354Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C…Guangzhou Hehong Biotech Co., Ltd. · 2026 · 3 generations on0descendants
  • K243373Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter -…Vitrolife Sweden AB · 2025 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K990350Wallace Catheters-18CM, Model 1816; 23CM, Model 1816N; 23CM, Model 2316CooperSurgical, Inc.1999—
+1K033084Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer CatheterPortex, Ltd.20036
+2K162878Kitazato ET CathetersKitazato Corporation2017—
+1K023379Coopersurgical Embryo Transfer Catheter, Coopersurgical Assisted Reproduction…Cooper Surgical2002—
+3K253354Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175…Guangzhou Hehong Biotech Co., Ltd.2026—
+3K243373Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter…Vitrolife Sweden AB2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200610
201730
202510
202610
FIG. 1 — Lineage of K990350, 1999–2026Source: 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.

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

Top candidate predicates for a new MQF device

  1. #1 K253354 Minvitro Embryo Transfer Catheters (ETCA23175…score 11.4 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K033084Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer CatheterPortex, Ltd.20035
K023379Coopersurgical Embryo Transfer Catheter, Coopersurgical Assisted Reproduction CatheterCooper Surgical20021
K053208Clear Vision Embryo Transfer Catheter Set, Model B100000 - B 100007; Clear Vision Trial…Swemed Lab International AB20060

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 28, 2013Class IIZ-1241-2013Process controlUnable to pass catheter through outer sheath during embryo transfer
Mar 28, 2013Class IIZ-1239-2013Process controlUnable to pass catheter through outer sheath during embryo transfer
Mar 28, 2013Class IIZ-1243-2013Process controlUnable to pass catheter through outer sheath during embryo transfer
Mar 28, 2013Class IIZ-1240-2013Process controlUnable to pass catheter through outer sheath during embryo transfer
Mar 28, 2013Class IIZ-1244-2013Process controlUnable to pass catheter through outer sheath during embryo transfer
Mar 28, 2013Class IIZ-1242-2013Process controlUnable to pass catheter through outer sheath during embryo transfer

The 5 latest of 6 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K033084 (Portex, Ltd., 2003) has gone furthest, with 5 descendants of its own.

How does its category compare?

All MQF devices

MQF Catheter, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQF

1in 2025

2010: 12012: 22013: 12015: 22017: 62018: 52019: 22020: 22022: 12023: 12024: 12025: 12026 (partial year): 1
2007high 6 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQF

196in 2018

2017: 230 days median2018: 196 days median
2007high 230 (2017) · low 196 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQF

2in 2019

2007: 62019: 2
2007high 6 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQF

13in 2025

2007: 22010: 32014: 32015: 22016: 32017: 102018: 272019: 162020: 192021: 132022: 112023: 122024: 152025: 13
2007high 27 (2018) · low 0 (2008)2025

MAUDE reports naming product code MQF, 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—62
20080—00
20090—00
20101—03
20110—00
20122—00
20131—00
20140—03
20152—02
20160—03
20176230010
20185196027
20192—216
20202—019
20210—013
20221—011
20231—012
20241—015
20251—013
20261—0—

What is it indicated for?

For the introduction of embryo(s) or washed spermatozoa into the uterine cavity during assisted reproductive 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 CooperSurgical, Inc.

121 FDA decisions under this applicant name. See the company

  • K261083Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)CooperSurgical, Inc. · 2026
  • K243799Fetal PillowCooperSurgical, Inc. · 2025
  • K250438CooperSurgical Milex® PessariesCooperSurgical, Inc. · 2025
  • P160047/S039Mara Water Vapor Ablation SystemCooperSurgical, Inc. · 2025
  • P160047/S035MARA Water Vapor Ablation SystemCooperSurgical, Inc. · 2024

Recent decisions in MQF

The MQF category page

  • K253354Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET…Guangzhou Hehong Biotech Co., Ltd. · 2026
  • K243373Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF…Vitrolife Sweden AB · 2025
  • K240307VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)Shenzhen Vitavitro Biotech Co., Ltd. · 2024
  • K231730FemaSeed Intratubal InseminationFemasys, Inc. · 2023
  • K220010Daylily Single Use Sterile Embryo Transfer CatheterShanghai Horizon Medical Technology Co., Ltd. · 2022

https://510kreport.com/device/K990350 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990350: Wallace Catheters-18CM, Model 1816; 23CM, Model 1816N; 23CM, Model 2316.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990350

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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