Bird Products Corp.: FDA filings under this applicant name
FDA lists 35 510(k) clearances under the applicant name “Bird Products Corp.” (first 1980, latest 2004), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 154 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 21 | 21 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 5 | 5 |
| BZD | Ventilator, Non-Continuous (Respirator) | 3 | 3 |
| BTI | Compressor, Air, Portable | 1 | 1 |
| BYL | Tent, Oxygen | 1 | 1 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 1 | 1 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 1 | 1 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 | 1 |
| CBC | Bottle, Collection And Trap, Breathing System (Uncalibrated) | 1 | 1 |
Review panels
- Anesthesiology (34)
- General Hospital (1)
Most recent Bird Products Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032451 | BIRD TBIRD VELA VENTILATOR | CBK | 2004-03-17 | 219 |
| K022674 | BIRD AVEA VENTILATOR | CBK | 2002-11-06 | 86 |
| K020730 | ORION NASAL CPAP SYSTEM | BZD | 2002-05-22 | 77 |
| K013642 | AVEA | CBK | 2002-05-22 | 198 |
| K020746 | BIRD TBIRD VELA VENTILATOR | CBK | 2002-04-22 | 46 |
| K003770 | BIRD TBIRD LEGACY VENTILATOR | CBK | 2000-12-15 | 9 |
| K990856 | HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682 | BZD | 2000-01-11 | 302 |
| K993449 | BIRD V.I.P. GOLD/STERLING | CBK | 1999-12-20 | 69 |
| K982580 | BIRD MONITOR INTERFACE | CBK | 1998-10-22 | 90 |
| K981971 | TBIRD VS/AVS VOLUME VENTILATOR, MODELS 15568, 15570 , LP10 VOLUME VENTILATOR WITH PRESSURE LIMIT MODEL 00-004130, BEAR 3 | CBK | 1998-08-24 | 81 |
25 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bird Products Corp..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Bird Life Design (7 510(k)s)
- Bird & Cronin, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bird Products Corp.?
FDA lists 35 510(k) clearances under the applicant name “Bird Products Corp.” (first 1980, latest 2004), across 9 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 Bird Products Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bird Products Corp. is 154 days.
Which FDA product codes appear under Bird Products Corp.?
The most frequent FDA product codes under this applicant name are CBK (Ventilator, Continuous, Facility Use, 21); BZR (Mixer, Breathing Gases, Anesthesia Inhalation, 5); BZD (Ventilator, Non-Continuous (Respirator), 3).
Next steps
- See all 35 Bird Products Corp. clearances with predicates and recalls
- Run predicate analysis for product code CBK, Bird Products Corp.'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.