Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Zoll Circulation, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
191 daysmedian FDA review time
291 days90th percentile
8clearances 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 |
| K231182 | Thermogard HQ™ Temperature Management System, Thermogard XP® | Zoll Circulation, Inc. | 2023-11-03 | 191 | 0 |
| K221700 | AutoPulse NXT Resuscitation System | Zoll Circulation, Inc. | 2023-03-09 | 269 | 1 |
| K223746 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intr | Zoll Circulation, Inc. | 2023-01-13 | 30 | 0 |
| K220008 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intr | Zoll Circulation, Inc. | 2022-06-02 | 149 | 0 |
| K213031 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intr | Zoll Circulation, Inc. | 2021-12-20 | 90 | 0 |
| K153226 | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up | Zoll Circulation, Inc. | 2016-03-24 | 139 | 0 |
| K150046 | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Ca | Zoll Circulation, Inc. | 2015-10-30 | 291 | 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