IME
27 FDA 510(k) clearances · Product code
30 daysmedian time to decision
170 days90th percentile
27clearances measured
FDA profile
- Official device name
- Pack, Hot Or Cold, Reusable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5700
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2014: 8 · 2015: 11 · 2016: 24 · 2017: 15 · 2018: 17 · 2026: 57
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| COLD PACK (K923627) | Friendmed Products | 1993-04-14 |
| HOTPAD (K915876) | Ten Comfort Corp. | 1993-02-12 |
| HOT OR COLD PACK (THERMIPAQ) (K921446) | Thermionics Corp. | 1992-07-13 |
| MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS (K905207) | Micro Surgical Instruments Corp. | 1991-01-22 |
| SUBOCCIPITAL ICE PILLOW (K882413) | Ferguson Medical | 1988-11-30 |
| RE-HEATER, HOT PACK (K863654) | K & L Ent. | 1986-10-23 |
| NICE PACK (K832193) | Universal Medical Instrument Corp. | 1983-08-31 |
| ENSWELL (K831899) | Dr. Micheal A. Sabia | 1983-07-07 |
| MICROPAK MOIST HEAT PAD (K830981) | Micropak Manufacturers, Inc. | 1983-06-03 |
| ICY COLD ICE CAP (K830416) | Ladora Ent. | 1983-03-10 |
| THERMOELASTOMER HOT/COLD COMPRESS BK7186 (K823649) | Fred Sammons, Inc. | 1983-01-21 |
| THERMOELASTOMER HOT/COLD COMPRESS-7187- (K823650) | Fred Sammons, Inc. | 1983-01-21 |
| HOT/COLD PACK HOLDERS (K823814) | Danek Medical, Inc. | 1983-01-14 |
| FLEX ICE FREEZE PACK (K822783) | Igloo Corp. | 1982-10-06 |
| ATTACH-A-PAK (K821636) | Fred Sammons, Inc. | 1982-06-11 |
| COLD ROLL (K820901) | North Bank Labs, Inc. | 1982-04-15 |
| COLD-HOT PACK (K820068) | Hospital Marketing Services Co., Inc. | 1982-01-28 |
| REUSEABLE HOT & COLD PACKS (K810451) | Fred Sammons, Inc. | 1981-03-04 |
| ACE COLD BANDAGE (K810402) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-03-04 |
| COLD/HOT PACK (K803299) | W.G. Whitney Corp. | 1981-01-15 |
| COLD PACK #589 (K801776) | Sunbeam Corp. | 1980-08-07 |
| KOLD WRAP (K801365) | Romaine, Inc. | 1980-08-07 |
| TRU-COLD THERAPY PAK (K800917) | Tru-Eze Mfg. Co., Inc. | 1980-05-02 |
| ICE CONTAINER I.C.E. (K792182) | Delta Medical Industries | 1979-11-15 |
| WARM-EE HEAT PACK (K791684) | U.S. Export Marketing Group, Inc. | 1979-10-30 |
| ICE PACK, REUSABLE FLEXIBLE (K790009) | Ackrad Laboratories | 1979-01-22 |
| ICE BAND (K771002) | Norcliff Thayer, Inc. | 1977-08-30 |
Track IME automatically
Every clearance here is in the API, with alerts when new ones post.