FDA product code HXD: Clamp
HXD is the FDA product code for clamp. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 14 510(k) submissions under HXD, from 10 different applicants. The average 510(k) review took 16 days (median 14). FDA has posted 4 recalls for HXD devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Clamp |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HXD clearance
Top HXD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kinetic Medical Products | 4 | 1989-02-03 |
| Robert I. Chien & Assoc., Inc. | 2 | 1980-08-20 |
| Solway, Inc. | 1 | 1987-12-30 |
| Med-Tool, Inc. | 1 | 1987-07-02 |
| B&B Medical Technologies, Inc. | 1 | 1986-10-07 |
5 more applicants have HXD clearances. See the full list in Caduvo.
Most recent HXD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K890372 | Kinetic Medical Products | INTESTINAL CLAMP | 1989-02-03 | 11 |
| K890371 | Kinetic Medical Products | INTESTINAL CRUSHING CLAMP | 1989-02-03 | 11 |
| K890381 | Kinetic Medical Products | PARAMETRIUM CLAMP | 1989-02-03 | 11 |
| K890368 | Kinetic Medical Products | KIDNEY CLAMP | 1989-02-03 | 11 |
| K874959 | Solway, Inc. | VASCULAR CLAMP | 1987-12-30 | 28 |
Recalls for HXD devices
4 product recalls in 4 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-01-31.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2024 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code HXD?
HXD is the FDA product code for clamp. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is HXD?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HXD?
Across 14 cleared submissions the average was 16 days from receipt to decision (median 14).
Which companies have the most HXD clearances?
Kinetic Medical Products (4); Robert I. Chien & Assoc., Inc. (2); Solway, Inc. (1); Med-Tool, Inc. (1); B&B Medical Technologies, Inc. (1).
Have HXD devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2025-01-31.
Next steps
- Run an FDA pathway report with predicate devices for product code HXD
- Run a recall and safety report across every HXD manufacturer
- Watch product code HXD 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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