FDA product code HFW: Clamp, Umbilical
HFW is the FDA product code for clamp, umbilical. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 36 510(k) submissions under HFW, from 30 different applicants. The average 510(k) review took 120 days (median 79). FDA has posted 1 recall for HFW devices.
Classification
| Field | Value |
|---|---|
| Device name | Clamp, Umbilical |
| Device class | Class II |
| Regulation | 21 CFR 884.4530 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HFW clearance
Top HFW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Maternus, Inc. | 3 | 2004-06-25 |
| Precision Dynamics Corp. | 3 | 2002-06-03 |
| Busse Hospital Disposables, Inc. | 2 | 2002-04-29 |
| Hollister, Inc. | 2 | 1990-07-26 |
| Kaen Yih Enterprise Co., Ltd. | 1 | 2004-03-11 |
25 more applicants have HFW clearances. See the full list in Caduvo.
Most recent HFW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K041332 | Maternus, Inc. | JOEY CLAMP OPENING TOOL | 2004-06-25 | 37 |
| K033846 | Kaen Yih Enterprise Co., Ltd. | KAEN YIH UMBILICAL CORD CLAMP | 2004-03-11 | 91 |
| K020718 | Precision Dynamics Corp. | SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE | 2002-06-03 | 90 |
| K021055 | Busse Hospital Disposables, Inc. | BUSSE UMBILICAL CORD CLAMP CUTTER | 2002-04-29 | 28 |
| K012917 | Dynarex Corp. | DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B | 2001-11-28 | 90 |
Recalls for HFW devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-04-15.
Frequently asked questions
What is FDA product code HFW?
HFW is the FDA product code for clamp, umbilical. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.
What device class is HFW?
Class II, regulation 21 CFR 884.4530. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HFW?
Across 36 cleared submissions the average was 120 days from receipt to decision (median 79).
Which companies have the most HFW clearances?
Maternus, Inc. (3); Precision Dynamics Corp. (3); Busse Hospital Disposables, Inc. (2); Hollister, Inc. (2); Kaen Yih Enterprise Co., Ltd. (1).
Have HFW devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-04-15.
Next steps
- Run an FDA pathway report with predicate devices for product code HFW
- Run a recall and safety report across every HFW manufacturer
- Watch product code HFW 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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