FDA product code IMD: Pack, Hot Or Cold, Disposable
IMD is the FDA product code for pack, hot or cold, disposable. It is a Class I device, regulated under 21 CFR 890.5710 and reviewed by the Physical Medicine panel. FDA has cleared 82 510(k) submissions under IMD, 1 in the last five years, from 61 different applicants. The average 510(k) review took 75 days (median 48). FDA has posted 26 recalls for IMD devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Pack, Hot Or Cold, Disposable |
| Device class | Class I |
| Regulation | 21 CFR 890.5710 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
510(k) clearances per year for IMD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 244 |
| 2022 | 1 | 121 |
Compare with all 510(k) review times · Search every IMD clearance
Top IMD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Omni Therm, Inc. | 4 | 1996-09-04 |
| Prism Technologies, Inc. | 4 | 1995-10-30 |
| Allegiance Healthcare Corp. | 3 | 1999-01-21 |
| Consolidated Products & Services, Inc. | 3 | 1997-11-19 |
| Anago, Inc. | 3 | 1993-05-26 |
56 more applicants have IMD clearances. See the full list in Caduvo.
Most recent IMD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K221653 | International Biomedical | InfaTherm Disposable Infant Warming Mattress | 2022-10-06 | 121 |
| K163295 | Rapid Aid Corp. | Infant Transport Mattress Warmer with Disc | 2017-07-24 | 244 |
| K112547 | Denovo Proucts, LLC | NEO NEST | 2012-03-06 | 187 |
| K082087 | Bio-Lipid, Inc. | EYEFEEL OPHTHALMIC WARMER | 2008-09-11 | 50 |
| K071710 | Johnson & Johnson Consumer Products, Inc. | BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) | 2007-08-14 | 53 |
Recalls for IMD devices
26 product recalls in 13 recall events; 7 initiated in the last five years and 7 still open. Most recent: 2024-08-27.
| Year | Recalls |
|---|---|
| 2018 | 3 |
| 2019 | 3 |
| 2021 | 4 |
| 2024 | 3 |
Frequently asked questions
What is FDA product code IMD?
IMD is the FDA product code for pack, hot or cold, disposable. It is a Class I device, regulated under 21 CFR 890.5710 and reviewed by the Physical Medicine panel.
What device class is IMD?
Class I, regulation 21 CFR 890.5710. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IMD?
Across 82 cleared submissions the average was 75 days from receipt to decision (median 48).
Which companies have the most IMD clearances?
Omni Therm, Inc. (4); Prism Technologies, Inc. (4); Allegiance Healthcare Corp. (3); Consolidated Products & Services, Inc. (3); Anago, Inc. (3).
Have IMD devices been recalled?
Yes: 26 product recalls across 13 recall events; the most recent began 2024-08-27.
Next steps
- Run an FDA pathway report with predicate devices for product code IMD
- Run a recall and safety report across every IMD manufacturer
- Watch product code IMD 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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