FDA product code HTD: Forceps
HTD is the FDA product code for forceps. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 73 510(k) submissions under HTD, from 25 different applicants. The average 510(k) review took 45 days (median 28). FDA has posted 14 recalls for HTD devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Forceps |
| 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 HTD clearance
Top HTD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kinetic Medical Products | 14 | 1989-02-03 |
| Imm Enterprises , Ltd. | 14 | 1984-05-01 |
| The Huxley Instrument Corp. | 9 | 1985-07-15 |
| Arthropedics, Inc. | 8 | 1987-11-02 |
| Titan Mfg., Inc. | 3 | 1998-06-24 |
20 more applicants have HTD clearances. See the full list in Caduvo.
Most recent HTD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K051281 | E.D.Medical , Ltd. | THE NEEDLE CATCHER | 2005-09-08 | 114 |
| K974594 | Titan Mfg., Inc. | SEMKIN BIPOLAR FORCEP | 1998-06-24 | 197 |
| K974595 | Titan Mfg., Inc. | CUSHING BAYONET, INSULATED BIPOLAR FORCEP | 1998-06-24 | 197 |
| K974593 | Titan Mfg., Inc. | SEMKIN INSULATED BIPOLAR FORCEP | 1998-06-24 | 197 |
| K913964 | Marlo Surgical Technology | MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS | 1991-10-23 | 48 |
Recalls for HTD devices
14 product recalls in 10 recall events; 4 initiated in the last five years and 6 still open. Most recent: 2025-01-31.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2022 | 2 |
| 2024 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code HTD?
HTD is the FDA product code for forceps. 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 HTD?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HTD?
Across 73 cleared submissions the average was 45 days from receipt to decision (median 28).
Which companies have the most HTD clearances?
Kinetic Medical Products (14); Imm Enterprises , Ltd. (14); The Huxley Instrument Corp. (9); Arthropedics, Inc. (8); Titan Mfg., Inc. (3).
Have HTD devices been recalled?
Yes: 14 product recalls across 10 recall events; the most recent began 2025-01-31.
Next steps
- Run an FDA pathway report with predicate devices for product code HTD
- Run a recall and safety report across every HTD manufacturer
- Watch product code HTD 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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