Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LHC — Predicate Candidate Screening
24 FDA 510(k) clearances under this product code; the 50 most recent screened below.
71 daysmedian FDA review time
179 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K153713 | Getinge Series Warming Cabinet | Getinge Sourcing, LLC | 2016-06-07 | 166 | 0 |
| K152522 | ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes | Ecolab, Inc. | 2016-01-15 | 134 | 0 |
| K150190 | IntraTemp Solution Warmer | Ecolab, Inc. | 2015-02-26 | 30 | 0 |
| K142173 | NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE | Ecolab, Inc. | 2014-12-30 | 145 | 0 |
| K142080 | NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH | Ecolab, Inc. | 2014-08-28 | 28 | 9 |
| K083417 | INTRATEMP SOLUTION WARMER | C Change Surgical, LLC | 2009-01-13 | 56 | 0 |
| K080609 | SWC/DWC WARMING CABINETS | Mac Medical | 2008-06-13 | 102 | 0 |
| K051819 | C CHANGE SOLUTION WARMER | C Change Surgical, LLC | 2005-08-15 | 41 | 0 |
| K023282 | ORS-3000LD | O.R. Solutions, Inc. | 2002-11-13 | 43 | 1 |
| K023283 | 1075LD HUSH-SLUSH | O.R. Solutions, Inc. | 2002-11-13 | 43 | 0 |
| K021288 | ORS-1000LD | O.R. Solutions, Inc. | 2002-06-27 | 65 | 1 |
| K021289 | WARMER 2000LD | O.R. Solutions, Inc. | 2002-06-26 | 64 | 0 |
| K002859 | SSW-STERILE SOLUTION WARMER | Kmi Kolster Methods, Inc. | 2000-11-16 | 64 | 0 |
| K965136 | UROSURGE UROTHERM FLUID WARMING SYSTEM | Princeton Regulatory Assoc. | 1998-10-16 | 662 | 0 |
| K971117 | WARMETTE | Olympic Medical Corp. | 1997-08-22 | 148 | 0 |
| K951300 | NEZHAT-DORSEY THERMAL RETENTION SYSTEM | American Hydro-Surgical Instruments, Inc. | 1995-06-20 | 90 | 0 |
| K932538 | CABOT MEDICAL IRRIGATION FLUID WARMER SETS | Cabot Medical Corp. | 1994-02-22 | 272 | 0 |
| K933726 | MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM | Augustine Medical, Inc. | 1994-01-28 | 179 | 0 |
| K921633 | ORS-2000 SERIES | Mnlase, Inc. | 1992-06-02 | 57 | 0 |
| K880876 | C-STAT/1000 | Sonne Medical, Inc. | 1988-05-20 | 80 | 0 |
| K880252 | THERMAL-PAK MODEL SW 1000 | Micro Tek Engineering | 1988-02-10 | 21 | 0 |
| K833944 | STERILE SOLUTION WARMER | National Fabtronix, Inc. | 1984-01-25 | 71 | 0 |
| K832642 | ALPHA-I | Johnson Flexgroup | 1983-11-21 | 109 | 0 |
| K811524 | AQUACADE | Respiratory Care, Inc. | 1981-07-01 | 33 | 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