510(k) · Cleared
ClearedWallace Trial Transfer Catheter, Model TT 1816N
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
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.
- Decided
- Jul 26, 1999
- Review
- 171 days
- Class
- Class II
- Product code
- MQF
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK990348 Wallace Trial Transfer Catheter, Model TT 1816NCooperSurgical, Inc. · 1999
- Descendant · cites it directly · 5 of its ownK033084 Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer…Portex, Ltd. · 2003 · Recalled
- Descendant · 2 generations on · 2 of its ownK162878 Kitazato ET CathetersKitazato Corporation · 2017
- Descendant · cites it directly · 1 of its ownK023384 Coopersurgical Trial Transfer CatheterCooper Surgical · 2002
- Descendant · 3 generations on · 0 of its ownK253354 Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C…Guangzhou Hehong Biotech Co., Ltd. · 2026
- 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
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
- K023384Coopersurgical Trial Transfer 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990348 | Wallace Trial Transfer Catheter, Model TT 1816N | CooperSurgical, Inc. | 1999 | — |
| +1 | K033084 | Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer Catheter | Portex, Ltd. | 2003 | 6 |
| +2 | K162878 | Kitazato ET Catheters | Kitazato Corporation | 2017 | — |
| +1 | K023384 | Coopersurgical Trial Transfer Catheter | Cooper Surgical | 2002 | — |
| +3 | K253354 | Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175… | Guangzhou Hehong Biotech Co., Ltd. | 2026 | — |
| +3 | K243373 | Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter… | Vitrolife Sweden AB | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 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?
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.
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, K033084 (Portex, Ltd., 2003) has gone furthest, with 5 descendants of its own.
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?
The Wallace Trial Transfer Catheter is a sterile single-use device intended to assess advancement through the cervical canal and positioning of the uterus.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990348 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990348: Wallace Trial Transfer Catheter, Model TT 1816N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990348
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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