Warren E. Collins, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Warren E. Collins, Inc.” (first 1978, latest 1994), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 71 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 |
|---|---|---|---|
| BZC | Calculator, Pulmonary Function Data | 4 | 4 |
| BTY | Calculator, Predicted Values, Pulmonary Function | 2 | 2 |
| BZG | Spirometer, Diagnostic | 2 | 2 |
| BXR | Meter, Airway Pressure (Inspiratory Force) | 1 | 1 |
| BYP | Mouthpiece, Breathing | 1 | 1 |
| BZL | Computer, Oxygen-Uptake | 1 | 1 |
| CCM | Plethysmograph, Pressure | 1 | 1 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 1 | 1 |
| ISD | Exerciser, Measuring | 1 | 1 |
Review panels
- Anesthesiology (13)
- Physical Medicine (1)
Most recent Warren E. Collins, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K925459 | GS-MODULAR (GOLD STANDARD - MODULAR) | BZG | 1994-02-04 | 463 |
| K912946 | COLLINS DIGITAL PULMONARY MANOMETER | BXR | 1992-01-15 | 194 |
| K871151 | THE SPIRA ELEKTRO 2 | CCQ | 1987-05-15 | 53 |
| K861227 | COLLINS PNEUMOTACH PFT SYSTEM | BZG | 1986-06-05 | 65 |
| K852102 | COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEM | CCM | 1985-07-31 | 77 |
| K831780 | METABOLIC EXERCISE TESTING SYSTEM | BZL | 1983-09-12 | 102 |
| K831778 | RS-RESIDUAL VOLUME SYSTEM | BZC | 1983-08-31 | 90 |
| K831777 | COLLINS DS | BZC | 1983-08-31 | 90 |
| K831779 | COLLINS EAGLE II | BZC | 1983-08-26 | 85 |
| K803069 | SHELL KRATON THERMO-PLASTIC RUBBER COMP. | BYP | 1980-12-22 | 17 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Warren E. Collins, 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.
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.
- Warren C. Miller (1 510(k)s)
- Warren J. Grosjean (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Warren E. Collins, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Warren E. Collins, Inc.” (first 1978, latest 1994), 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 Warren E. Collins, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Warren E. Collins, Inc. is 71 days.
Which FDA product codes appear under Warren E. Collins, Inc.?
The most frequent FDA product codes under this applicant name are BZC (Calculator, Pulmonary Function Data, 4); BTY (Calculator, Predicted Values, Pulmonary Function, 2); BZG (Spirometer, Diagnostic, 2).
Next steps
- See all 14 Warren E. Collins, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BZC, Warren E. Collins, 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, 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.