510(k) · Cleared
Recalled · Class II · 2013Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Portex, Ltd. · MQF Catheter, Assisted Reproduction
Cleared on Dec 19, 2003 as substantially equivalent to K990350 (CooperSurgical, Inc., 1999) and 2 other predicates after an 81-day review. Its family tree reaches back 1 generation to 1998. 5 later devices descend from it. It has been recalled 6 times.
- Decided
- Dec 19, 2003
- Review
- 81 days
- Class
- Class II
- Product code
- MQF
- Recalls
- 6
- Predicates
- 3
Its longest line of descent runs back 1 generation to K983594 (1998). 3 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK983594 Embryo Transfer Catheters/SetsCook Ob/Gyn · 1998 · Recalled
- This deviceK033084 Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer…Portex, Ltd. · 2003
- Descendant · cites it directly · 2 of its ownK162878 Kitazato ET CathetersKitazato Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK253354 Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C…Guangzhou Hehong Biotech Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK243373 Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo…Vitrolife Sweden AB · 2025
- Descendant · cites it directly · 0 of its ownK161547 Transem and EchoGen Embryo Transfer CathetersOrigio A/S · 2017
- Descendant · cites it directly · 0 of its ownK162064 CrossBay IVF Embryo Transfer Catheter SetCrossbay Medical, Inc. · 2017
Most influential descendants
Showing 5 of 5 · See all- K162878Kitazato ET CathetersKitazato Corporation · 2017 · cites it directly2descendants
- K253354Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C…Guangzhou Hehong Biotech Co., Ltd. · 2026 · 2 generations on0descendants
- K243373Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter -…Vitrolife Sweden AB · 2025 · 2 generations on0descendants
- K161547Transem and EchoGen Embryo Transfer CathetersOrigio A/S · 2017 · cites it directly0descendants
- K162064CrossBay IVF Embryo Transfer Catheter SetCrossbay Medical, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983594 | Embryo Transfer Catheters/Sets | Cook Ob/Gyn | 1998 | 3 |
| 0 (this device) | K033084 | Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer Catheter | Portex, Ltd. | 2003 | — |
| +1 | K162878 | Kitazato ET Catheters | Kitazato Corporation | 2017 | — |
| +2 | K253354 | Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175… | Guangzhou Hehong Biotech Co., Ltd. | 2026 | — |
| +2 | K243373 | Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter… | Vitrolife Sweden AB | 2025 | — |
| +1 | K161547 | Transem and EchoGen Embryo Transfer Catheters | Origio A/S | 2017 | — |
| +1 | K162064 | CrossBay IVF Embryo Transfer Catheter Set | Crossbay Medical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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
What was it cleared against? (3)
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 | Decided |
|---|---|---|---|
| * | K990350 | Wallace Catheters-18CM, Model 1816; 23CM, Model 1816N; 23CM, Model 2316Summary page 1…Class 11 MQF, 21 CFR 884.611 0 PREDICATE DEVICES: * Predicate 1: Wallace Embryo Transfer Catheter range 18-23cm already marketed in the USA under K990350 * Predicate 2: Wallace Trial Transfer Catheter range 18-23cm already marketed in the USA under K990348 * Predic… | 1999 |
| * | K990348 | Wallace Trial Transfer Catheter, Model TT 1816NSummary page 1…ange 18-23cm already marketed in the USA under K990350 * Predicate 2: Wallace Trial Transfer Catheter range 18-23cm already marketed in the USA under K990348 * Predicate 3: Cook Echotipa Soft-Pass Embryo Transfer Catheter already marketed in the USA under K983 594… | 1999 |
| * | K983594 | Embryo Transfer Catheters/SetsSummary page 1…nge 18-23cm already marketed in the USA under K990348 * Predicate 3: Cook Echotipa Soft-Pass Embryo Transfer Catheter already marketed in the USA under K983 594 Section 5 - Page 1 of 3 Wallace (Sure View TM) Emb… | 1998 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 28, 2013 | Class II | Z-1241-2013 | Process control | Unable to pass catheter through outer sheath during embryo transfer |
| Mar 28, 2013 | Class II | Z-1239-2013 | Process control | Unable to pass catheter through outer sheath during embryo transfer |
| Mar 28, 2013 | Class II | Z-1243-2013 | Process control | Unable to pass catheter through outer sheath during embryo transfer |
| Mar 28, 2013 | Class II | Z-1240-2013 | Process control | Unable to pass catheter through outer sheath during embryo transfer |
| Mar 28, 2013 | Class II | Z-1244-2013 | Process control | Unable to pass catheter through outer sheath during embryo transfer |
| Mar 28, 2013 | Class II | Z-1242-2013 | Process control | Unable 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?
How does its category compare?
All MQF devicesMQF Catheter, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQF
196in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQF
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQF
13in 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?
Embryo Replacement Catheters are sterile, single-use devices for ultrasound guided introduction of embryos into the uterine cavity following in vitro fertilisation.
Trial Transfer Catheters are sterile, single-use devices for determining whether the cervix is passable for a Wallace embryo replacement catheter
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033084 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033084: Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033084
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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