Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Zoll Circulation — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
154 daysmedian FDA review time
194 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141139 | SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER | Zoll Circulation | 2014-10-03 | 154 | 0 |
| K112998 | AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 | Zoll Circulation | 2012-03-15 | 160 | 1 |
| K101987 | COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3 | Zoll Circulation | 2010-10-12 | 90 | 0 |
| K072527 | AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 | Zoll Circulation | 2008-03-19 | 194 | 1 |
| K063602 | AUTOPULSE RESUSCITATION SYSTEM MODEL100 | Zoll Circulation | 2006-12-21 | 17 | 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