Cygnus Research Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Cygnus Research Corp.” (first 1983, latest 1983), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 41 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 |
|---|---|---|---|
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 3 | 3 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 2 | 2 |
Review panels
- Anesthesiology (5)
Most recent Cygnus Research Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K831556 | VAPOR-PHASE HUMIDIFIER SYSTEM | BTT | 1983-07-19 | 64 |
| K831163 | LO-COMP RESERVOIR-RE-1000 | BTT | 1983-05-03 | 22 |
| K830923 | TEMP-CHECK ADAPTOR, STRAIGHT CONFIGURA | BZO | 1983-05-03 | 42 |
| K830922 | TEMP-CHECK ADAPTOR, TEE-CONFIGURATION | BZO | 1983-05-02 | 41 |
| K830921 | TEMP-CHECK ADAPTOR, Y-CONFIGURATION | BZO | 1983-05-02 | 41 |
Recalls
openFDA lists no recalls under a recalling firm named Cygnus Research 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.
- Cygnus Instruments, Inc. (2 510(k)s)
- Cygnus of South Florida, Inc. (2 510(k)s)
- Cygnus, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cygnus Research Corp.?
FDA lists 5 510(k) clearances under the applicant name “Cygnus Research Corp.” (first 1983, latest 1983), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cygnus Research Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cygnus Research Corp. is 41 days.
Which FDA product codes appear under Cygnus Research Corp.?
The most frequent FDA product codes under this applicant name are BZO (Set, Tubing And Support, Ventilator (W Harness), 3); BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 2).
Next steps
- See all 5 Cygnus Research Corp. clearances with predicates and recalls
- Run predicate analysis for product code BZO, Cygnus Research 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 (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.