Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nova-Ventrx — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
147 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K952267 | CRITERION, CRITERION I.V., MODIFIED | Nova-Ventrx | 1997-12-02 | 932 | 0 |
| K954480 | CONDENSATE COLLECTION KIT | Nova-Ventrx | 1995-12-29 | 94 | 0 |
| K893760 | CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004 | Nova-Ventrx | 1989-08-10 | 83 | 0 |
| K881207 | RES-Q 1, 2, 3, 4 AND 5 | Nova-Ventrx | 1988-08-15 | 147 | 0 |
| K870382 | DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 3011 | Nova-Ventrx | 1987-03-06 | 36 | 0 |
| K863756 | MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT | Nova-Ventrx | 1986-11-13 | 49 | 0 |
| K850600 | CO-AX VENTILATOR CIRCUIT | Nova-Ventrx | 1985-05-02 | 76 | 0 |
| K842795 | MAXI-MISER HUMIDIFIER INSERT 1030 | Nova-Ventrx | 1984-10-04 | 79 | 0 |
| K842794 | MAXI-MISER HUMIDIFIER INSERT 1020 & 1021 | Nova-Ventrx | 1984-10-04 | 79 | 0 |
| K841571 | MAXI-MISER WATER TRANSFER SET 1021/1022 | Nova-Ventrx | 1984-05-30 | 43 | 0 |
| K841569 | MAXI-MISER HUMIDIFIER INSERT 1020 | Nova-Ventrx | 1984-05-30 | 43 | 0 |
| K812737 | RAIN-X | Nova-Ventrx | 1981-10-23 | 24 | 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