Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Survivalink Corp. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
141 daysmedian FDA review time
373 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011901 | FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200 | Survivalink Corp. | 2002-02-01 | 228 | 2 |
| K010214 | FIRSTSAVE BIPHASIC MODEL #9200 AND 9210 | Survivalink Corp. | 2001-02-22 | 30 | 1 |
| K993072 | SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630) | Survivalink Corp. | 1999-12-10 | 87 | 0 |
| K982264 | FIRSTSAVE BIPHASIC MODELS 9200 AND 9210 | Survivalink Corp. | 1999-01-25 | 210 | 0 |
| K970481 | V2 | Survivalink Corp. | 1997-07-01 | 141 | 0 |
| K971149 | SVL-9130 DEFIBRILLATION ELECTRODE | Survivalink Corp. | 1997-06-23 | 87 | 1 |
| K940445 | VIVALINK AED DEFIBRILLATOR | Survivalink Corp. | 1995-02-09 | 373 | 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