Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Survival Technology, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
58 daysmedian FDA review time
108 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K925535 | CARDIOBEEPER(R) CB-IIA | Survival Technology, Inc. | 1993-01-28 | 87 | 0 |
| K894799 | CARDIOBEEPER MEMORY MONITOR CB 600 SERIES | Survival Technology, Inc. | 1989-10-03 | 67 | 0 |
| K890461 | CARDIOBEEPER IV | Survival Technology, Inc. | 1989-02-23 | 24 | 0 |
| K883843 | CARDIOBEEPER II | Survival Technology, Inc. | 1988-11-09 | 58 | 0 |
| K883614 | CYTOGUARD(R) | Survival Technology, Inc. | 1988-09-15 | 22 | 0 |
| K880300 | CARDIOBEEPER(R) III | Survival Technology, Inc. | 1988-05-12 | 108 | 0 |
| K844966 | CARDIOBEEPER PROFILE MONITOR | Survival Technology, Inc. | 1985-02-08 | 46 | 0 |
| K822093 | STAT-SCAN | Survival Technology, Inc. | 1982-09-21 | 67 | 0 |
| K813101 | CARDIOBEEPER MEMORY MONITOR | Survival Technology, Inc. | 1981-11-27 | 24 | 0 |
| K772178 | PACER MONITOR, PULSE WIDTH | Survival Technology, Inc. | 1977-12-08 | 16 | 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