Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nasiff Assoc., Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
182 daysmedian FDA review time
207 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K993616 | CARDIO-CARD INTERPRETATION SYSTEM I | Nasiff Assoc., Inc. | 2000-04-10 | 167 | 0 |
| K972795 | CARDIO-CARD MANAGEMENT SYSTEM II | Nasiff Assoc., Inc. | 1998-02-20 | 207 | 0 |
| K960544 | CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM | Nasiff Assoc., Inc. | 1996-08-07 | 182 | 0 |
| K920020 | CARDIO-CARD ECG MANAGEMENT SYSTEM | Nasiff Assoc., Inc. | 1992-07-09 | 189 | 0 |
| K903722 | MICROMED QRS CARD | Nasiff Assoc., Inc. | 1990-12-05 | 112 | 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