Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alternative Design Systems, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
95 daysmedian FDA review time
217 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K874719 | STRATUM ESU | Alternative Design Systems, Inc. | 1988-02-16 | 91 | 0 |
| K874697 | STRATUM D | Alternative Design Systems, Inc. | 1987-12-15 | 26 | 0 |
| K854757 | 5000 SERIES ECG ELECTRODES | Alternative Design Systems, Inc. | 1986-04-23 | 147 | 0 |
| K853633 | TENS CONDUCTIVE MEDIA PAD | Alternative Design Systems, Inc. | 1985-12-03 | 95 | 0 |
| K852515 | ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR | Alternative Design Systems, Inc. | 1985-06-24 | 11 | 0 |
| K830778 | MONITORING KIT AMK-1 | Alternative Design Systems, Inc. | 1983-10-14 | 217 | 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