Nova-Ventrx: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Nova-Ventrx” (first 1981, latest 1997), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 78 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 4 | 4 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 2 | 2 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 | 1 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 1 | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 | 1 |
| CBP | Valve, Non-Rebreathing | 1 | 1 |
Plus 1 more product codes.
Review panels
- Anesthesiology (10)
Most recent Nova-Ventrx 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952267 | CRITERION, CRITERION I.V., MODIFIED | BZE | 1997-12-02 | 932 |
| K954480 | CONDENSATE COLLECTION KIT | CAI | 1995-12-29 | 94 |
| K893760 | CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004 | BZO | 1989-08-10 | 83 |
| K881207 | RES-Q 1, 2, 3, 4 AND 5 | BTM | 1988-08-15 | 147 |
| K870382 | DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 3011 | CBP | 1987-03-06 | 36 |
| K863756 | MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT | BZO | 1986-11-13 | 49 |
| K850600 | CO-AX VENTILATOR CIRCUIT | BZO | 1985-05-02 | 76 |
| K842795 | MAXI-MISER HUMIDIFIER INSERT 1030 | BTT | 1984-10-04 | 79 |
| K842794 | MAXI-MISER HUMIDIFIER INSERT 1020 & 1021 | BTT | 1984-10-04 | 79 |
| K841571 | MAXI-MISER WATER TRANSFER SET 1021/1022 | — | 1984-05-30 | 43 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nova-Ventrx.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Nova-Ventrx?
FDA lists 12 510(k) clearances under the applicant name “Nova-Ventrx” (first 1981, latest 1997), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nova-Ventrx?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nova-Ventrx is 78 days.
Which FDA product codes appear under Nova-Ventrx?
The most frequent FDA product codes under this applicant name are BZO (Set, Tubing And Support, Ventilator (W Harness), 4); BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 2); BTM (Ventilator, Emergency, Manual (Resuscitator), 1).
Next steps
- See all 12 Nova-Ventrx clearances with predicates and recalls
- Run predicate analysis for product code BZO, Nova-Ventrx's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.