FDA product code MDM: Instrument, Manual, Surgical, General Use
MDM is the FDA product code for instrument, manual, surgical, general use. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 44 510(k) submissions under MDM, from 37 different applicants. The average 510(k) review took 140 days (median 123). FDA has posted 76 recalls for MDM devices, 10 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Manual, Surgical, General Use |
| 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 MDM clearance
Top MDM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Savoy Medical Supply Co., Inc. | 4 | 1993-05-24 |
| Falcon Instruments, Inc. | 3 | 1993-04-23 |
| Acuderm, Inc. | 2 | 1994-03-07 |
| Deroyal Industries, Inc. | 2 | 1991-05-13 |
| Injectimed, Inc. | 1 | 2008-08-08 |
32 more applicants have MDM clearances. See the full list in Caduvo.
Most recent MDM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K073664 | Injectimed, Inc. | FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER | 2008-08-08 | 226 |
| K050575 | Futumeds Sdn Bhd | FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM | 2005-08-15 | 161 |
| K050957 | Special Devices, Inc. | EUTROCHAR | 2005-05-18 | 33 |
| K023173 | Andrews Surgical Innovations, Ltd. | ANDREWS INTRODUCER, MODEL ASI01 | 2002-12-18 | 86 |
| K022059 | Boston Scientific Corp | MICROVASIVE PULMONARY GUIDEWIRE | 2002-11-13 | 141 |
Recalls for MDM devices
76 product recalls in 23 recall events; 10 initiated in the last five years and 9 still open. Most recent: 2025-03-03.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2018 | 2 |
| 2021 | 1 |
| 2022 | 3 |
| 2024 | 5 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code MDM?
MDM is the FDA product code for instrument, manual, surgical, general use. 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 MDM?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MDM?
Across 44 cleared submissions the average was 140 days from receipt to decision (median 123).
Which companies have the most MDM clearances?
Savoy Medical Supply Co., Inc. (4); Falcon Instruments, Inc. (3); Acuderm, Inc. (2); Deroyal Industries, Inc. (2); Injectimed, Inc. (1).
Have MDM devices been recalled?
Yes: 76 product recalls across 23 recall events; the most recent began 2025-03-03.
Next steps
- Run an FDA pathway report with predicate devices for product code MDM
- Run a recall and safety report across every MDM manufacturer
- Watch product code MDM 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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