510(k) · Cleared
Recalled · Class II · 2013Wallace Malleable Stylet-18CM, Model 1816ST, Wallace Malleable Stylet-23CM, Model 1816NST
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. 1 later device descends 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
1 later device descends from it, 1 citing it directly.
- This deviceK990349 Wallace Malleable Stylet-18CM, Model 1816ST, Wallace Malleable…CooperSurgical, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK053208 Clear Vision Embryo Transfer Catheter Set, Model B100000 - B 100007…Swemed Lab International AB · 2006
Most influential descendants
Showing 1 of 1 · See all- K053208Clear Vision Embryo Transfer Catheter Set, Model B100000 - B 100007; Clear Vision Trial…Swemed Lab International AB · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990349 | Wallace Malleable Stylet-18CM, Model 1816ST, Wallace Malleable Stylet-23CM… | CooperSurgical, Inc. | 1999 | — |
| +1 | K053208 | Clear Vision Embryo Transfer Catheter Set, Model B100000 - B 100007; Clear… | Swemed Lab International AB | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053208 | Clear Vision Embryo Transfer Catheter Set, Model B100000 - B 100007; Clear Vision Trial… | 2006 | 0 |
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?
- Of its descendants, K053208 (Swemed Lab International AB, 2006) has gone furthest, with 0 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 Family of Wallace Malleable Stylets are a sterile single-use device intended to be used in conjunction with a Wallace Catheter for in vitro fertilization procedures where passage through the cervix is impeded.
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/K990349 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990349: Wallace Malleable Stylet-18CM, Model 1816ST, Wallace Malleable Stylet-23CM, Model 1816NST.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990349
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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