FDA product code HDW: Diaphragm, Contraceptive (And Accessories)
HDW is the FDA product code for diaphragm, contraceptive (and accessories). It is a Class II device, regulated under 21 CFR 884.5350 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 4 510(k) submissions under HDW, from 4 different applicants. The average 510(k) review took 226 days (median 216). FDA has posted 3 recalls for HDW devices.
Classification
| Field | Value |
|---|---|
| Device name | Diaphragm, Contraceptive (And Accessories) |
| Device class | Class II |
| Regulation | 21 CFR 884.5350 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every HDW clearance
Top HDW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kessel Medintim GmbH | 1 | 2014-08-26 |
| Johnson & Johnson Produtos Profissionais Ltda. | 1 | 2008-08-25 |
| CooperSurgical, Inc. | 1 | 2008-01-23 |
| G.D. Searle and Co. | 1 | 1980-02-11 |
Most recent HDW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K140305 | Kessel Medintim GmbH | CAYA CONTOURED DIAPHRAGM | 2014-08-26 | 200 |
| K080040 | Johnson & Johnson Produtos Profissionais Ltda. | ORTHO ALL-FLEX DIAPHRAGM | 2008-08-25 | 231 |
| K063223 | CooperSurgical, Inc. | MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS | 2008-01-23 | 456 |
| K800162 | G.D. Searle and Co. | ONCE TM | 1980-02-11 | 17 |
Recalls for HDW devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-02-16.
Frequently asked questions
What is FDA product code HDW?
HDW is the FDA product code for diaphragm, contraceptive (and accessories). It is a Class II device, regulated under 21 CFR 884.5350 and reviewed by the Obstetrics and Gynecology panel.
What device class is HDW?
Class II, regulation 21 CFR 884.5350. Typical premarket route: 510(k).
How long does a 510(k) take for product code HDW?
Across 4 cleared submissions the average was 226 days from receipt to decision (median 216).
Which companies have the most HDW clearances?
Kessel Medintim GmbH (1); Johnson & Johnson Produtos Profissionais Ltda. (1); CooperSurgical, Inc. (1); G.D. Searle and Co. (1).
Have HDW devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2016-02-16.
Next steps
- Run an FDA pathway report with predicate devices for product code HDW
- Run a recall and safety report across every HDW manufacturer
- Watch product code HDW 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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