Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Physio-Control, Inc. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
271 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253099 | LIFEPAK 15 AC Power Adapter (41577-000333) | Physio-Control, Inc. | 2025-10-14 | 20 | 0 |
| K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with IC | Physio-Control, Inc. | 2024-04-30 | 102 | 0 |
| K182503 | Sterilizable Internal Defibrillation Paddles for use with LI | Physio-Control, Inc. | 2019-06-03 | 264 | 1 |
| K142430 | LIFEPAK 15 monitor/defibrillator | Physio-Control, Inc. | 2014-12-19 | 112 | 4 |
| K130454 | LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/ | Physio-Control, Inc. | 2013-08-21 | 180 | 1 |
| K123597 | TRUECPR COACHING DEVICE | Physio-Control, Inc. | 2013-04-17 | 147 | 0 |
| K122600 | LIFEPAK 1000 DEFIBRILLATOR | Physio-Control, Inc. | 2012-10-11 | 45 | 1 |
| K103567 | LIFEPAK 15 MONITOR/DEFIBRILLATOR | Physio-Control, Inc. | 2011-03-22 | 106 | 0 |
| K102972 | LIFEPAK 12 | Physio-Control, Inc. | 2010-12-22 | 77 | 0 |
| K102757 | LIFENET SYSTEM | Physio-Control, Inc. | 2010-11-05 | 43 | 0 |
| K093925 | LIFENET SYSTEM | Physio-Control, Inc. | 2010-01-12 | 21 | 0 |
| K082937 | LIFEPAK 15 MONITOR/DEFIBRILLATOR | Physio-Control, Inc. | 2009-03-11 | 161 | 2 |
| K073089 | LIFEPAK 20E | Physio-Control, Inc. | 2008-07-29 | 271 | 1 |
| K832833 | PERSONAL DEFIBRILLATOR | Physio-Control, Inc. | 1984-10-26 | 434 | 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