Pegasus Research Corp.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Pegasus Research Corp.” (first 1988, latest 2012), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 160 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 | 1 | 50 |
| 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 |
|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 5 | 5 |
| CAF | Nebulizer (Direct Patient Interface) | 5 | 5 |
| BWF | Spirometer, Therapeutic (Incentive) | 1 | 1 |
| BYH | Drain, Tee (Water Trap) | 1 | 1 |
Review panels
- Anesthesiology (12)
Most recent Pegasus Research Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122857 | HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100 | CAF | 2012-11-07 | 50 |
| K020700 | PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY | BTT | 2004-04-26 | 784 |
| K013856 | PMH 1000 HEATED HUMIDIFIER | BTT | 2003-02-21 | 472 |
| K983783 | HEATED HUMIDIFIER | BTT | 2000-10-24 | 728 |
| K962534 | THERA-MIST NEBULIZER MODEL-P3000 | CAF | 1997-02-28 | 245 |
| K946057 | AQUALARM MOISTURE SENSOR MODEL P85000 | BYH | 1995-05-05 | 144 |
| K915890 | AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED | BTT | 1992-06-24 | 183 |
| K914465 | AUTOCLAVABLE VERSION THERA-MIST NEBULIZER, P32000 | CAF | 1992-03-31 | 176 |
| K903489 | THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000 | BWF | 1990-12-10 | 130 |
| K894000 | THERA-MIST HUMIDIFIER | BTT | 1989-08-28 | 84 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pegasus 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Pegasus Research Corp. (a text match, not an official crosswalk):
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.
- Pegasus Biologics, Inc. (5 510(k)s)
- Pegasus Airwave, Inc. (4 510(k)s)
- Pegasus Medical Supply, Inc. (2 510(k)s)
- Pegasus Imaging Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pegasus Research Corp.?
FDA lists 12 510(k) clearances under the applicant name “Pegasus Research Corp.” (first 1988, latest 2012), across 4 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 Pegasus Research Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pegasus Research Corp. is 160 days.
Which FDA product codes appear under Pegasus Research Corp.?
The most frequent FDA product codes under this applicant name are BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 5); CAF (Nebulizer (Direct Patient Interface), 5); BWF (Spirometer, Therapeutic (Incentive), 1).
Next steps
- See all 12 Pegasus Research Corp. clearances with predicates and recalls
- Run predicate analysis for product code BTT, Pegasus 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, 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.