Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
IMD — Predicate Candidate Screening
82 FDA 510(k) clearances under this product code; the 50 most recent screened below.
49 daysmedian FDA review time
170 days90th percentile
82clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221653 | InfaTherm Disposable Infant Warming Mattress | International Biomedical | 2022-10-06 | 121 | 0 |
| K163295 | Infant Transport Mattress Warmer with Disc | Rapid Aid Corp. | 2017-07-24 | 244 | 0 |
| K112547 | NEO NEST | Denovo Proucts, LLC | 2012-03-06 | 187 | 0 |
| K082087 | EYEFEEL OPHTHALMIC WARMER | Bio-Lipid, Inc. | 2008-09-11 | 50 | 0 |
| K071710 | BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOU | Johnson & Johnson Consumer Products, Inc. | 2007-08-14 | 53 | 0 |
| K021843 | EYEFEEL OPHTHALMIC WARMER | Bio-Lipid, Inc. | 2002-09-03 | 90 | 0 |
| K982652 | ALLEGIANCE PORTA-WARM MATTRESS | Allegiance Healthcare Corp. | 1999-01-21 | 175 | 0 |
| K980509 | DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS | Deroyal Industries, Inc. | 1998-02-26 | 16 | 0 |
| K974190 | CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER | Consolidated Products & Services, Inc. | 1997-11-19 | 15 | 0 |
| K973770 | ALLEGIANCE KWIK HEAT WARM PERINEAL PACK | Allegiance Healthcare Corp. | 1997-11-13 | 42 | 0 |
| K970399 | KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD) | Allegiance Healthcare Corp. | 1997-04-03 | 59 | 0 |
| K963689 | RECOVER ADULT VEIN WARMER | Florida Medical Industries, Inc. | 1996-12-12 | 87 | 0 |
| K963768 | INSTANT HOT PACKS | Kick Ice, Inc. | 1996-11-25 | 67 | 0 |
| K963666 | INSTANT COLD PACK | Kick Ice, Inc. | 1996-10-30 | 47 | 0 |
| K963220 | TEMPRA COLD PACK, REORDER NO. TC150 | Tempo Technology, Inc. | 1996-10-10 | 55 | 0 |
| K961176 | OMNI COLD GEL PACKS | Omni Therm, Inc. | 1996-09-04 | 163 | 0 |
| K955788 | IMNI HOT PACKS | Omni Therm, Inc. | 1996-09-04 | 257 | 0 |
| K951033 | ANDELA DYNAMIC COOLING DEVICE | Candela Laser Corp. | 1996-08-15 | 528 | 0 |
| K960624 | CERTI COOL INSTANT COLD COMPRESS | Certified Safety Mfg., Inc. | 1996-05-06 | 83 | 0 |
| K954877 | OMNI COLD GEL PACKS | Omni Therm, Inc. | 1996-02-13 | 112 | 0 |
| K953442 | RESTORE, THERMACELLS (HOT PACK I) | Neal Dunning Assoc., Inc. | 1995-10-31 | 106 | 0 |
| K953542 | COLDGEL | Prism Technologies, Inc. | 1995-10-30 | 94 | 0 |
| K953541 | INSTANT COLDGEL | Prism Technologies, Inc. | 1995-10-05 | 69 | 0 |
| K950680 | INFANT HEEL WARMER | Baxter Healthcare Corp | 1995-08-23 | 190 | 0 |
| K951383 | TEMPRA HEAT PACK | Tempra Technology, Inc. | 1995-06-01 | 66 | 0 |
| K941245 | POLY-MEDICS HEAT PACK | Biomet, Inc. | 1994-05-02 | 48 | 0 |
| K936084 | OMNI WARM GEL PACKS | Omni Therm, Inc. | 1994-03-31 | 100 | 6 |
| K940336 | CERTI HEAT INSTANT HEAT COMPRESS | Certified Safety Mfg., Inc. | 1994-03-07 | 41 | 0 |
| K935569 | INSTANT HOT OR COLD DISPOSABLE PACK | Cryopak Industries, Inc. | 1994-03-07 | 109 | 0 |
| K934631 | TRANSWARMER | Prism Technologies, Inc. | 1994-02-03 | 132 | 1 |
| K934673 | KACEY DISPOSABLE INFANT HEEL WARMER | K & C Medical, Inc. | 1994-02-02 | 125 | 0 |
| K920760 | PERI-K PAD COLD PACK | Baxter Healthcare Corp | 1993-07-29 | 526 | 0 |
| K926137 | ANAGO FEM-COOL/FEM-COOL PETITE | Anago, Inc. | 1993-05-26 | 170 | 0 |
| K926590 | ANAGO DISPOSABLE INSTANT COLD PACK | Anago, Inc. | 1993-05-26 | 170 | 0 |
| K926589 | ANAGO WARM PACK | Anago, Inc. | 1993-05-26 | 170 | 0 |
| K920252 | CURAD KID SIZE INSTANT COLD PACK | Kendall Healthcare Products Co. Div.Of Tyco Health | 1992-02-11 | 21 | 0 |
| K912715 | INSTANT WARM GEL PACK | Prism Technologies, Inc. | 1991-10-02 | 106 | 4 |
| K904819 | SHUR-LOCK ICE WRAP SYSTEM | Conco Medical Co. | 1990-12-06 | 43 | 0 |
| K902839 | LIBERTY HOT PACK AND LIBERTY KOLD PACK | Liberty Ent. | 1990-07-25 | 27 | 0 |
| K901834 | INSTANT ICE PACK | Impact Packaging Corp. | 1990-05-03 | 9 | 0 |
| K901778 | 3M HEAT COMFORT PORTABLE SELF-HEATING PAD | 3M Company | 1990-05-01 | 14 | 0 |
| K895860 | MEDI-PACK | Heatmax Mfg., Inc. | 1990-01-02 | 91 | 0 |
| K894926 | STAT-PAD | Hettel Accessories, Inc. | 1989-09-05 | 34 | 0 |
| K890924 | THERMO-PACK | Medical Manufacturers, Inc. | 1989-03-14 | 18 | 0 |
| K890553 | CP&S DISPOSABLE INSTANT COLD COMPRESS | Consolidated Products & Services, Inc. | 1989-02-13 | 7 | 0 |
| K890554 | CP&S DISPOSABLE INSTANT SUPER HOT COMPRESS | Consolidated Products & Services, Inc. | 1989-02-13 | 7 | 0 |
| K883966 | HARE COLD PACK | Dyna Industries, Inc. | 1988-09-30 | 10 | 0 |
| K880871 | GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER | John Wagner Associates, Inc. | 1988-05-20 | 80 | 0 |
| K873364 | HYPERTHERM TECHNOLOGIES' HEAT COMPRESS | Hypertherm Technologies, Inc. | 1987-11-17 | 88 | 0 |
| K871168 | INSTANT COLD COMPRESS, CHEMICAL TYPE | Lexington Industries | 1987-04-06 | 13 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda