FDA product code MFD: Cannula, Intrauterine Insemination
MFD is the FDA product code for cannula, intrauterine insemination. It is a Class II device, regulated under 21 CFR 884.5250 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 29 510(k) submissions under MFD, from 20 different applicants. The average 510(k) review took 236 days (median 89). FDA has posted 1 recall for MFD devices.
Classification
| Field | Value |
|---|---|
| Device name | Cannula, Intrauterine Insemination |
| Device class | Class II |
| Regulation | 21 CFR 884.5250 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every MFD clearance
Top MFD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Life-Tech Intl., Inc. | 4 | 1993-09-07 |
| Select Medical Systems, Inc. | 2 | 2001-10-11 |
| Medworks Corp. | 2 | 1999-01-14 |
| A & A Medical, Inc. | 2 | 1997-10-10 |
| Marlo Surgical Technology | 2 | 1996-07-31 |
15 more applicants have MFD clearances. See the full list in Caduvo.
Most recent MFD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K021438 | Labotect Labor-Technik Gottingen | INSEMINATION CATHETER, MODEL 320301 | 2002-07-16 | 71 |
| K012935 | Select Medical Systems, Inc. | THECURVE, ITEM 507 | 2001-10-11 | 41 |
| K984306 | Wallach Surgical Devices, Inc. | `THE INSEMINATOR' (PROPOSED) | 1999-03-01 | 89 |
| K982630 | Medworks Corp. | MEDWORKS VISUALIZATION INSEMINATION CATHETER | 1999-01-14 | 170 |
| K982628 | Medworks Corp. | MEDWORKS INSEMINATION CATHETER | 1998-08-21 | 24 |
Recalls for MFD devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-02-28.
| Year | Recalls |
|---|---|
| 2020 | 1 |
Frequently asked questions
What is FDA product code MFD?
MFD is the FDA product code for cannula, intrauterine insemination. It is a Class II device, regulated under 21 CFR 884.5250 and reviewed by the Obstetrics and Gynecology panel.
What device class is MFD?
Class II, regulation 21 CFR 884.5250. Typical premarket route: 510(k).
How long does a 510(k) take for product code MFD?
Across 29 cleared submissions the average was 236 days from receipt to decision (median 89).
Which companies have the most MFD clearances?
Life-Tech Intl., Inc. (4); Select Medical Systems, Inc. (2); Medworks Corp. (2); A & A Medical, Inc. (2); Marlo Surgical Technology (2).
Have MFD devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2020-02-28.
Next steps
- Run an FDA pathway report with predicate devices for product code MFD
- Run a recall and safety report across every MFD manufacturer
- Watch product code MFD 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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