Unicor, Inc.: FDA clearances and approvals
Unicor, Inc. has 5 FDA 510(k) clearances (first 1995, latest 1995), across 3 product codes in 1 review panel. Median 510(k) review time: 36 days.
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) | 2 | 2 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 2 | 2 |
| BZA | Connector, Airway (Extension) | 1 | 1 |
Review panels
- Anesthesiology (5)
Most recent Unicor, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953788 | UNICOR, INC. GAS SAMPLING LINES & CONNECTORS | CAI | 1995-09-19 | 36 |
| K953787 | UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT | CAI | 1995-09-19 | 36 |
| K953786 | UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS | BZA | 1995-09-19 | 36 |
| K953784 | UNICOR, INC. CORRUGATED TUBING | BZO | 1995-09-19 | 36 |
| K953785 | UNICOR, INC. VENTILATOR HOSES | BZO | 1995-09-18 | 35 |
Recalls
openFDA lists no recalls under a recalling firm named Unicor, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Unicor, Inc. have?
Unicor, Inc. has 5 FDA 510(k) clearances (first 1995, latest 1995), across 3 product codes in 1 review panel.
How long does FDA take to clear Unicor, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Unicor, Inc.'s cleared 510(k)s is 36 days.
What devices does Unicor, Inc. make?
Its most frequent FDA product codes are BZO (Set, Tubing And Support, Ventilator (W Harness), 2); CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece), 2); BZA (Connector, Airway (Extension), 1).
Has Unicor, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Unicor, Inc. Related entities may recall under other names.
Next steps
- See all 5 Unicor, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BZO, Unicor, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.