Bird Life Design: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Bird Life Design” (first 1993, latest 1993), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 90 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) | 4 | 4 |
| CAH | Filter, Bacterial, Breathing-Circuit | 2 | 2 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 1 | 1 |
Review panels
- Anesthesiology (5)
- General Hospital (2)
Most recent Bird Life Design 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K931487 | BLD HEATED BREATHING CIRCUIT W/EXHALATION VALVE | CAI | 1993-12-16 | 267 |
| K934190 | HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION | BYD | 1993-11-24 | 90 |
| K934189 | BARRIERFLEX-I, AND BARRIERFLES-II | CAH | 1993-11-24 | 90 |
| K934540 | BARRIERFLEX-PF PULMONARY FUNCTION TESTING FILTER | CAH | 1993-10-19 | 33 |
| K933641 | BLD NEONATAL HEATED WIRE BREATHING CIRCUIT- 30 VOLT COMPATIBLE | CAI | 1993-10-15 | 80 |
| K925543 | BLD-18000 SERIES HEATED BREATHING CIRCUIT | CAI | 1993-04-30 | 176 |
| K930252 | BABYSET AND PAC (PULMONARY ASSIST CIRCUIT) | CAI | 1993-02-09 | 32 |
Recalls
openFDA lists no recalls under a recalling firm named Bird Life Design.
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 Products Corp. (35 510(k)s)
- Bird & Cronin, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bird Life Design?
FDA lists 7 510(k) clearances under the applicant name “Bird Life Design” (first 1993, latest 1993), across 3 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 Life Design?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bird Life Design is 90 days.
Which FDA product codes appear under Bird Life Design?
The most frequent FDA product codes under this applicant name are CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece), 4); CAH (Filter, Bacterial, Breathing-Circuit, 2); BYD (Condenser, Heat And Moisture (Artificial Nose), 1).
Next steps
- See all 7 Bird Life Design clearances with predicates and recalls
- Run predicate analysis for product code CAI, Bird Life Design'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.