510(k) · Cleared

Cleared

Clear Vision Embryo Transfer Catheter Set, Model B100000 - B 100007; Clear Vision Trial Transfer Catheter Set

K053208510(k) AbbreviatedCleared Jan 30, 200675-day reviewClass II21 CFR 884.6110

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

Swemed Lab International AB · MQF Catheter, Assisted Reproduction

Cleared on Jan 30, 2006 as substantially equivalent to K990350 (CooperSurgical, Inc., 1999) and 5 other predicates after a 75-day review. Its family tree reaches back 2 generations to 1999.

Decided: Jan 30, 2006
Review: 75 days
Class: Class II
Product code: MQF
Recalls: None
Predicates: 6

Its longest line of descent runs back 2 generations to K990350 (1999). 6 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK990350 Wallace Catheters-18CM, Model 1816; 23CM, Model 1816N; 23CM, Model…CooperSurgical, Inc. · 1999 · Recalled
1 generation backK023379 Coopersurgical Embryo Transfer Catheter, Coopersurgical Assisted…Cooper Surgical · 2002
This deviceK053208 Clear Vision Embryo Transfer Catheter Set, Model B100000 - B 100007…Swemed Lab International AB · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K990350	Wallace Catheters-18CM, Model 1816; 23CM, Model 1816N; 23CM, Model 2316	CooperSurgical, Inc.	1999	6
−1	K023379	Coopersurgical Embryo Transfer Catheter, Coopersurgical Assisted Reproduction…	Cooper Surgical	2002	—
0 (this device)	K053208	Clear Vision Embryo Transfer Catheter Set, Model B100000 - B 100007; Clear…	Swemed Lab International AB	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	2	0
2002	2	0

FIG. 1 — Lineage of K053208, 1999–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K253354 Minvitro Embryo Transfer Catheters (ETCA23175…score 11.4 · 3 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (6)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K990350	Wallace Catheters-18CM, Model 1816; 23CM, Model 1816N; 23CM, Model 2316 Summary page 1 …fication Name Assisted Reproduction Catheters PREDICATE DEVICES: a) Wallace Catheters already marketed in the USA under Premarket Notification K990350 b) CooperSurgical Embryo Transfer Catheter already marketed in the USA tindcl Premarket Notification K023379…	CooperSurgical, Inc.	1999	6
*	K023379	Coopersurgical Embryo Transfer Catheter, Coopersurgical Assisted Reproduction Catheter Summary page 1 …rs already marketed in the USA under Premarket Notification K990350 b) CooperSurgical Embryo Transfer Catheter already marketed in the USA tindcl Premarket Notification K023379 15(20) c) Wallace Trial Transfer Catheters already marketed in the USA u…	Cooper Surgical	2002	—
*	K990348	Wallace Trial Transfer Catheter, Model TT 1816N Summary page 2 …tion K023379 15(20) c) Wallace Trial Transfer Catheters already marketed in the USA under Premarket Notification K990348 d) CooperSurgical Trial Transfer Catheter already marketed in the USA under Premarket Notification K023384 e) Wallace Malleable…	CooperSurgical, Inc.	1999	—
*	K023384	Coopersurgical Trial Transfer Catheter Summary page 2 …ters already marketed in the USA under Premarket Notification K990348 d) CooperSurgical Trial Transfer Catheter already marketed in the USA under Premarket Notification K023384 e) Wallace Malleable Stylet already marketed in the USA under Premarket Notification K990349 f) CooperSurgical Malleable Stylet…	Cooper Surgical	2002	—
*	K990349	Wallace Malleable Stylet-18CM, Model 1816ST, Wallace Malleable Stylet-23CM, Model 1816NST Summary page 2 …Transfer Catheter already marketed in the USA under Premarket Notification K023384 e) Wallace Malleable Stylet already marketed in the USA under Premarket Notification K990349 f) CooperSurgical Malleable Stylet already marketed in the USA under Premarket Notification K023382. DEVICE DESCRIPTION: Embr…	CooperSurgical, Inc.	1999	6
*	K023382	Coopersurgical Malleable Sytlet Summary page 2 …able Stylet already marketed in the USA under Premarket Notification K990349 f) CooperSurgical Malleable Stylet already marketed in the USA under Premarket Notification K023382. DEVICE DESCRIPTION: Embryo Transfer Cathteter Set The Swemed Embryo Transfer Catheter Set is manufactured by Swemed of medica…	Cooper Surgical	2002	—

Also cleared against K990350: 2 other devices →

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 7 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
2 of the 6 ancestors have a recall of any class.
2 other devices also cite its predicate K990350.

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

2007high 6 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQF

196in 2018

2007high 230 (2017) · low 196 (2018)2026

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

Recalls per year · MQF

2in 2019

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	6	2
2008	0	—	0	0
2009	0	—	0	0
2010	1	—	0	3
2011	0	—	0	0
2012	2	—	0	0
2013	1	—	0	0
2014	0	—	0	3
2015	2	—	0	2
2016	0	—	0	3
2017	6	230	0	10
2018	5	196	0	27
2019	2	—	2	16
2020	2	—	0	19
2021	0	—	0	13
2022	1	—	0	11
2023	1	—	0	12
2024	1	—	0	15
2025	1	—	0	13
2026	1	—	0	—

What is it indicated for?

The embryo transfer catheter set is a sterile, single use device designed for in vitro

fertilized (IVF) embryo transfer into the uterine cavity.

The trial transfer catheter is a sterile, single use device which is designed for ensuring

a free passage through the cervix prior to the embryo transfer.

The stylet is a sterile, single-use device designed to support in initial placement of the

guide catheter prior to the embryo transfer.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K053208 · printed Nov 4, 2026

Cite this page

510(k) Report. “K053208: Clear Vision Embryo Transfer Catheter Set, Model B100000 - B 100007; Clear Vision Trial Transfer Catheter Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053208

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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