Prima, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Prima, Inc.” (first 1994, latest 1995), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 24 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 |
|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 8 | 8 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 5 | 5 |
| BZA | Connector, Airway (Extension) | 3 | 3 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 1 | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
Review panels
- Anesthesiology (18)
- General Hospital (1)
Most recent Prima, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952022 | PRIMA VOLUMN VENTILATORSS | BZO | 1995-05-22 | 24 |
| K952021 | PRIMA HYUPERINFLATION SYSTEM | BZR | 1995-05-22 | 24 |
| K952020 | PRIMA PEDIATRIC ANESTHESIA CIRCUITS | CAI | 1995-05-22 | 24 |
| K952019 | PRIMA ADULT GAS SAMPLING CIRCUITS | CAI | 1995-05-22 | 24 |
| K952018 | PRIMA COAXIAL CIRCUITS | CAI | 1995-05-22 | 24 |
| K952017 | PRIMA MAPLESON D CIRCUIT | CAI | 1995-05-22 | 24 |
| K952016 | PRIMA PEDIATRIC GAS SAMPLING CIRCUITS | CAI | 1995-05-22 | 24 |
| K952015 | PRIMA FILTER | CAH | 1995-05-22 | 24 |
| K952014 | PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS | CAI | 1995-05-22 | 24 |
| K952013 | PRIMA GUEDEL AIRWAYS | BTR | 1995-05-22 | 24 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Prima, Inc..
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 Prima, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Prima, Inc.” (first 1994, latest 1995), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Prima, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Prima, Inc. is 24 days.
Which FDA product codes appear under Prima, Inc.?
The most frequent FDA product codes under this applicant name are CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece), 8); BZO (Set, Tubing And Support, Ventilator (W Harness), 5); BZA (Connector, Airway (Extension), 3).
Next steps
- See all 19 Prima, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAI, Prima, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.