FDA product code IME: Pack, Hot Or Cold, Reusable
IME is the FDA product code for pack, hot or cold, reusable. It is a Class I device, regulated under 21 CFR 890.5700 and reviewed by the Physical Medicine panel. FDA has cleared 27 510(k) submissions under IME, from 24 different applicants. The average 510(k) review took 64 days (median 30). FDA has posted 12 recalls for IME devices, 10 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Pack, Hot Or Cold, Reusable |
| Device class | Class I |
| Regulation | 21 CFR 890.5700 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every IME clearance
Top IME applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fred Sammons, Inc. | 4 | 1983-01-21 |
| Friendmed Products | 1 | 1993-04-14 |
| Ten Comfort Corp. | 1 | 1993-02-12 |
| Thermionics Corp. | 1 | 1992-07-13 |
| Micro Surgical Instruments Corp. | 1 | 1991-01-22 |
19 more applicants have IME clearances. See the full list in Caduvo.
Most recent IME clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K923627 | Friendmed Products | COLD PACK | 1993-04-14 | 267 |
| K915876 | Ten Comfort Corp. | HOTPAD | 1993-02-12 | 421 |
| K921446 | Thermionics Corp. | HOT OR COLD PACK (THERMIPAQ) | 1992-07-13 | 108 |
| K905207 | Micro Surgical Instruments Corp. | MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS | 1991-01-22 | 63 |
| K882413 | Ferguson Medical | SUBOCCIPITAL ICE PILLOW | 1988-11-30 | 170 |
Recalls for IME devices
12 product recalls in 5 recall events; 10 initiated in the last five years and 10 still open. Most recent: 2025-09-25.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2021 | 1 |
| 2022 | 8 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code IME?
IME is the FDA product code for pack, hot or cold, reusable. It is a Class I device, regulated under 21 CFR 890.5700 and reviewed by the Physical Medicine panel.
What device class is IME?
Class I, regulation 21 CFR 890.5700. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IME?
Across 27 cleared submissions the average was 64 days from receipt to decision (median 30).
Which companies have the most IME clearances?
Fred Sammons, Inc. (4); Friendmed Products (1); Ten Comfort Corp. (1); Thermionics Corp. (1); Micro Surgical Instruments Corp. (1).
Have IME devices been recalled?
Yes: 12 product recalls across 5 recall events; the most recent began 2025-09-25.
Next steps
- Run an FDA pathway report with predicate devices for product code IME
- Run a recall and safety report across every IME manufacturer
- Watch product code IME 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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