Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MPD · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| 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 |
| K240162 | LIFEPAK® 35 AC Power Adapter (41335-000001) | Stryker Physio-Control | 2024-04-19 | 88 | 0 |
| K062331 | HIGHPAK-12 | Ad Elektronik GmbH | 2007-07-10 | 334 | 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