510(k) · Cleared
ClearedEmbryo Transfer Catheter with Accessory Stylet, Models 9018, 9023, 9018-S, 9023-S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inntec, Inc. · MQF Catheter, Assisted Reproduction
Cleared on May 2, 2005 as substantially equivalent to K992307 (Fertility Technology Resources, Inc., 1999) after a 62-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- May 2, 2005
- Review
- 62 days
- Class
- Class II
- Product code
- MQF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992307 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK992307 Embryo Glide Embryo Transfer Catheter, Embryo Glide Style for Embryo…Fertility Technology Resources, Inc. · 1999
- This deviceK050521 Embryo Transfer Catheter with Accessory Stylet, Models 9018, 9023…Inntec, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992307 | Embryo Glide Embryo Transfer Catheter, Embryo Glide Style for Embryo Transfer… | Fertility Technology Resources, Inc. | 1999 | — |
| 0 (this device) | K050521 | Embryo Transfer Catheter with Accessory Stylet, Models 9018, 9023, 9018-S… | Inntec, Inc. | 2005 | — |
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? (1)
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 |
|---|---|---|---|
| * | K992307 | Embryo Glide Embryo Transfer Catheter, Embryo Glide Style for Embryo Transfer CatheterSummary page 1…Manufacturer Product Class Trade Name Code K992307 Life Tech MQF I1 Embryo Glidem Embryo Medical, Inc.… | 1999 |
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?
- Its one ancestor has no recall.
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 InnTec, Inc. Embryo Transfer Catheter and Accessory Stylet is an assisted reproduction catheter used in IVF assisted reproduction procedures to introduce embryo(s) into the female uterus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050521: Embryo Transfer Catheter with Accessory Stylet, Models 9018, 9023, 9018-S, 9023-S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050521
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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