Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Heartsine Technologies, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
186 daysmedian FDA review time
460 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K142709 | samaritan PAD 450P | Heartsine Technologies, Inc. | 2015-03-27 | 186 | 0 |
| K123881 | HEARTSINE SAMARITAN PAD 350P | Heartsine Technologies, Inc. | 2013-07-11 | 206 | 1 |
| K052465 | REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AE | Heartsine Technologies, Inc. | 2006-12-12 | 460 | 2 |
| K042088 | SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301 | Heartsine Technologies, Inc. | 2004-09-02 | 30 | 0 |
| K041067 | HEARTSINE SAMARITAN PAD | Heartsine Technologies, Inc. | 2004-05-25 | 32 | 1 |
| K023854 | SAMARITAN AED, MODEL SAM-01 | Heartsine Technologies, Inc. | 2003-02-14 | 87 | 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