FDA product code EMF: Knife, Surgical
EMF is the FDA product code for knife, surgical. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 21 510(k) submissions under EMF, from 16 different applicants. The average 510(k) review took 65 days (median 56). FDA has posted 9 recalls for EMF devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Knife, Surgical |
| 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 EMF clearance
Top EMF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kinetic Medical Products | 3 | 1989-01-27 |
| A.M. Surgical, Inc. | 2 | 2008-03-13 |
| Imm Enterprises , Ltd. | 2 | 1984-01-27 |
| Nestor Engineering Associates, Inc. | 2 | 1978-10-03 |
| Van-Tec, Inc. | 1 | 1988-02-29 |
11 more applicants have EMF clearances. See the full list in Caduvo.
Most recent EMF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K080133 | A.M. Surgical, Inc. | MOUNTABLE ENDOSCOPIC BLADE | 2008-03-13 | 55 |
| K982142 | A.M. Surgical, Inc. | MOUNTABLE ENDOSCOPIC KNIFE | 1998-12-30 | 196 |
| K890215 | Kinetic Medical Products | MICROSURGICAL SCARIFIER | 1989-01-27 | 9 |
| K890214 | Kinetic Medical Products | MICROSURGERY RAZOR BLADE HOLDER | 1989-01-27 | 9 |
| K890217 | Kinetic Medical Products | MICROSURGICAL KNIVES | 1989-01-27 | 9 |
Recalls for EMF devices
9 product recalls in 5 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-05-07.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2018 | 1 |
| 2020 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code EMF?
EMF is the FDA product code for knife, surgical. 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 EMF?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EMF?
Across 21 cleared submissions the average was 65 days from receipt to decision (median 56).
Which companies have the most EMF clearances?
Kinetic Medical Products (3); A.M. Surgical, Inc. (2); Imm Enterprises , Ltd. (2); Nestor Engineering Associates, Inc. (2); Van-Tec, Inc. (1).
Have EMF devices been recalled?
Yes: 9 product recalls across 5 recall events; the most recent began 2025-05-07.
Next steps
- Run an FDA pathway report with predicate devices for product code EMF
- Run a recall and safety report across every EMF manufacturer
- Watch product code EMF 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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