FDA product code MQF: Catheter, Assisted Reproduction
MQF is the FDA product code for catheter, assisted reproduction. It is a Class II device, regulated under 21 CFR 884.6110 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 53 510(k) submissions under MQF, 5 in the last five years, from 28 different applicants. The average 510(k) review took 148 days (median 135); 199 days on average over the last three years. FDA has posted 36 recalls for MQF devices.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Assisted Reproduction |
| Device class | Class II |
| Regulation | 21 CFR 884.6110 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MQF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 6 | 219 |
| 2018 | 5 | 195 |
| 2019 | 2 | 142 |
| 2020 | 2 | 190 |
| 2022 | 1 | 346 |
| 2023 | 1 | 101 |
| 2024 | 1 | 196 |
| 2025 | 1 | 266 |
| 2026 | 1 | 135 |
Compare with all 510(k) review times · Search every MQF clearance
Top MQF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cook Incorporated | 7 | 2019-05-17 |
| Cook Ob/Gyn | 5 | 1999-02-08 |
| Cooper Surgical | 4 | 2002-12-20 |
| Kitazato Corporation | 3 | 2020-05-01 |
| Fertility Technology Resources, Inc. | 3 | 2004-11-22 |
23 more applicants have MQF clearances. See the full list in Caduvo.
Most recent MQF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253354 | Guangzhou Hehong Biotech Co., Ltd. | Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) | 2026-02-12 | 135 |
| K243373 | Vitrolife Sweden AB | Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511) | 2025-07-23 | 266 |
| K240307 | Shenzhen Vitavitro Biotech Co., Ltd. | VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) | 2024-08-16 | 196 |
| K231730 | Femasys, Inc. | FemaSeed Intratubal Insemination | 2023-09-22 | 101 |
| K220010 | Shanghai Horizon Medical Technology Co., Ltd. | Daylily Single Use Sterile Embryo Transfer Catheter | 2022-12-16 | 346 |
Recalls for MQF devices
36 product recalls in 6 recall events; 0 initiated in the last five years and 19 still open. Most recent: 2020-12-23.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2019 | 2 |
| 2020 | 19 |
Frequently asked questions
What is FDA product code MQF?
MQF is the FDA product code for catheter, assisted reproduction. It is a Class II device, regulated under 21 CFR 884.6110 and reviewed by the Obstetrics and Gynecology panel.
What device class is MQF?
Class II, regulation 21 CFR 884.6110. Typical premarket route: 510(k).
How long does a 510(k) take for product code MQF?
Across 53 cleared submissions the average was 148 days from receipt to decision (median 135).
Which companies have the most MQF clearances?
Cook Incorporated (7); Cook Ob/Gyn (5); Cooper Surgical (4); Kitazato Corporation (3); Fertility Technology Resources, Inc. (3).
Have MQF devices been recalled?
Yes: 36 product recalls across 6 recall events; the most recent began 2020-12-23.
Next steps
- Run an FDA pathway report with predicate devices for product code MQF
- Run a recall and safety report across every MQF manufacturer
- Watch product code MQF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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