Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ILO — Predicate Candidate Screening
93 FDA 510(k) clearances under this product code; the 50 most recent screened below.
92 daysmedian FDA review time
272 days90th percentile
93clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213097 | Armory Motion | Pain Management Technologies, Inc. | 2022-06-10 | 259 | 0 |
| K083008 | COOLSKIN | Elbio Co., Ltd. | 2009-06-10 | 245 | 0 |
| K073675 | T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP | Gaymar Industries, Inc. | 2008-05-08 | 132 | 1 |
| K072152 | JUNIPER CLN1 DERMAL COOLING DEVICE | Juniper Medical, Inc. | 2007-09-07 | 35 | 0 |
| K070402 | MODIFICATION TO POLAR CARE 500 | Breg, Inc. | 2007-03-29 | 45 | 0 |
| K040317 | IVC SYSTEM | Mark H. Friedman | 2004-05-07 | 88 | 0 |
| K973023 | INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET | Hollister, Inc. | 1997-11-03 | 81 | 0 |
| K970197 | HTP-1500 LOCALIZED HEAT THERAPY PUMP | Adroit Medical Systems, Inc. | 1997-09-10 | 232 | 0 |
| K964799 | ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY | Ormed GmbH | 1997-08-29 | 273 | 0 |
| K964354 | ARTOCOOL-S WATER CIRCULATING COLD PACK | Ormed GmbH | 1997-08-29 | 302 | 0 |
| K964710 | BLEDSOE COLD CONTROL | Med Technology, Inc. | 1997-05-09 | 165 | 0 |
| K970533 | MODEL 1100 COLD THERAPY DEVICE | Smith & Nephew, Inc. | 1997-04-15 | 62 | 0 |
| K962983 | STERILE SOFT-TEMP | Adroit Medical Systems, Inc. | 1997-01-10 | 162 | 0 |
| K964006 | INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES) | Hollister, Inc. | 1996-12-31 | 85 | 0 |
| K964057 | INCARE HOT/ICE SYSTEM SHOULDER BLANKET | Hollister, Inc. | 1996-12-31 | 83 | 0 |
| K963596 | POLAR CARE 300 | Breg, Inc. | 1996-12-04 | 86 | 0 |
| K962537 | INCARE HOT/ICE LITE MACHINE | Hollister, Inc. | 1996-11-27 | 152 | 0 |
| K961621 | THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM | Therapy Concepts, Inc. | 1996-10-31 | 188 | 0 |
| K961425 | BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MU | Bio Compression Systems, Inc. | 1996-10-28 | 199 | 0 |
| K963261 | EBI THERMAL THERAPY SYSTEM | Electro-Biology, Inc. | 1996-09-27 | 38 | 0 |
| K961855 | POLAR CARE (MODEL 500/50000) | Breg, Inc. | 1996-08-09 | 87 | 0 |
| K955529 | CRYTRON SYSTEM | Mark H. Friedman | 1996-06-10 | 189 | 0 |
| K955326 | SPORTS CONTRAST THERAPY SYSTEM ST 7000 | Burke Neutech, Inc. | 1996-04-10 | 142 | 0 |
| K955057 | MODEL 1100 COLD THERAPY DEVICE | Smith and Nephew Donjoy, Inc. | 1996-03-08 | 123 | 0 |
| K954095 | MEDICOOL (MODIFICATON) | Microclimate Systems, Inc. | 1996-03-06 | 199 | 0 |
| K945853 | THERMOTEK H-300 | Thermotek, Inc. | 1995-10-05 | 339 | 0 |
| K953532 | EBICE | Electro-Biology, Inc. | 1995-10-04 | 69 | 0 |
| K950395 | THERMOCOOL SYSTEM | Zimmer, Inc. | 1995-08-18 | 198 | 0 |
| K950711 | T-350 THERAPEUTIC COOLING MACHINE | Thermotek, Inc. | 1995-07-06 | 142 | 0 |
| K945468 | T-300 COOLER | Temptek, Inc. | 1995-06-19 | 223 | 0 |
| K943497 | CONTRAST 7000 THERAPY SYSTEM | Burke Neutech, Inc. | 1995-06-07 | 323 | 0 |
| K945467 | BABYTHERM 8000 WB | Drager, Inc. | 1995-04-28 | 172 | 0 |
| K934262 | HPRH HOSPITAL PATIENT RADIANT HEATER | Marley Electric Heating Co. | 1995-04-18 | 595 | 0 |
| K945399 | DELTA THERM COLD THERAPY SYSTEM | Deltatherm | 1995-03-07 | 123 | 0 |
| K944447 | COOL/HEAT THERAPY APPLICATOR | Medical Science Technology, Inc. | 1995-02-09 | 150 | 0 |
| K943844 | TOTALLY COOL(TM) TC-1 | Electro Science Technologies, Inc. | 1995-02-09 | 237 | 0 |
| K945067 | EBICE | Electro-Biology, Inc. | 1995-02-09 | 118 | 0 |
| K942882 | TOTALLY COOL(TM) TC-2 | Electro Science Technologies, Inc. | 1995-02-09 | 237 | 0 |
| K944971 | INCARE HOT/ICE COLD THERAPY COOLER | Hollister, Inc. | 1995-01-30 | 111 | 0 |
| K935841 | DR KOOL | Toronto Medical Corp. | 1994-08-29 | 265 | 0 |
| K936143 | ISOCOMFORTER | Isocomforter, Inc. | 1994-07-12 | 197 | 0 |
| K940858 | THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS) | Innovation Sports, Inc. | 1994-07-12 | 139 | 0 |
| K940429 | ORTHO TECH CRYOLOGIC SYSTEM | Orthopedic Technology, Inc. | 1994-07-12 | 162 | 0 |
| K940160 | TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM | Burke Neutech, Inc. | 1994-05-27 | 135 | 0 |
| K930918 | HYDROT | Sanker Intl., Inc. | 1994-05-25 | 462 | 0 |
| K931203 | COOL-AID | Seabrook Medical Systems, Inc. | 1994-02-22 | 350 | 0 |
| K931843 | HOT/ICE SYSTEM STERILE CONFORMABLE/DISP. BLANKETS | Hollister, Inc. | 1994-02-02 | 295 | 0 |
| K930634 | SUR FLO THERMAL THERAPY PADS | Buckman Co., Inc. | 1993-11-01 | 266 | 0 |
| K926151 | LSI6000 THERMAL THERAPY SYSTEM | Burke Neutech, Inc. | 1993-05-26 | 170 | 0 |
| K925677 | AUTOCHILL ACCESSORY KIT | Aircast, Inc. | 1993-04-14 | 272 | 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