Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NZE — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
236 daysmedian FDA review time
347 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250979 | Thermogard HQ™ Temperature Management System, Thermogard XP® | Zoll Circulation, Inc. | 2025-10-15 | 198 | 0 |
| K240933 | CarbonCool® System | Global Healthcare SG Sdn. Bhd | 2025-03-18 | 347 | 0 |
| K231182 | Thermogard HQ™ Temperature Management System, Thermogard XP® | Zoll Circulation, Inc. | 2023-11-03 | 191 | 0 |
| K162523 | The IQool System | Braincool AB | 2017-05-03 | 236 | 0 |
| K100071 | EMCOOLSPAD | Emcools Emergency Medical Cooling Systems AG | 2010-10-12 | 274 | 0 |
| K061023 | THERMOSUIT SYSTEM | Life Recovery Systems Hd, LLC | 2006-09-20 | 160 | 1 |
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