Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cincinnati Sub-Zero Products, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
105 daysmedian FDA review time
233 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123946 | WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO | Cincinnati Sub-Zero Products, Inc. | 2013-01-17 | 27 | 0 |
| K122813 | HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM | Cincinnati Sub-Zero Products, Inc. | 2012-12-18 | 96 | 3 |
| K121669 | WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKE | Cincinnati Sub-Zero Products, Inc. | 2012-07-03 | 27 | 0 |
| K120081 | NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS | Cincinnati Sub-Zero Products, Inc. | 2012-02-17 | 37 | 0 |
| K110104 | BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM | Cincinnati Sub-Zero Products, Inc. | 2011-02-04 | 22 | 2 |
| K101148 | WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS | Cincinnati Sub-Zero Products, Inc. | 2010-10-01 | 161 | 2 |
| K101589 | BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HY | Cincinnati Sub-Zero Products, Inc. | 2010-09-20 | 105 | 4 |
| K072621 | ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCO | Cincinnati Sub-Zero Products, Inc. | 2007-12-13 | 87 | 1 |
| K070339 | DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES | Cincinnati Sub-Zero Products, Inc. | 2007-09-26 | 233 | 0 |
| K942790 | WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133) | Cincinnati Sub-Zero Products, Inc. | 1995-01-24 | 225 | 0 |
| K942599 | WARM AIR WARMING UNIT | Cincinnati Sub-Zero Products, Inc. | 1995-01-24 | 237 | 3 |
| K910327 | WARMAIR SYSTEM | Cincinnati Sub-Zero Products, Inc. | 1991-05-16 | 111 | 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