Catalyst Research Corp.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Catalyst Research Corp.” (first 1978, latest 1991), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 37 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 |
|---|---|---|---|
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 4 | 4 |
| DQA | Oximeter | 3 | 3 |
| BXL | Algesimeter, Manual | 1 | 1 |
| CCJ | Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase | 1 | 1 |
Review panels
- Anesthesiology (9)
Most recent Catalyst Research Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K905310 | MINIOX V PULSE OXIMETER | DQA | 1991-05-28 | 181 |
| K874132 | MINIOX IV PORTABLE PULSE OXIMETER | DQA | 1988-01-19 | 98 |
| K862798 | MINIOX 100 PULSE OXIMETER | DQA | 1986-08-28 | 36 |
| K833995 | MINI OX II | CCL | 1983-12-12 | 21 |
| K833326 | MINI OX III OXYGEN MONITOR | BXL | 1983-11-03 | 37 |
| K790785 | MODEL M25RL, (CRC) OXYGEN ANALYZER | CCL | 1979-04-27 | 4 |
| K790784 | MODEL M25R, OXYGEN ANALYZER | CCL | 1979-04-27 | 4 |
| K782062 | ANALYZER, OXYGEN MODEL M25RA & M25RAD | CCL | 1979-02-15 | 70 |
| K781746 | MINICO | CCJ | 1978-12-05 | 48 |
Recalls
openFDA lists no recalls under a recalling firm named Catalyst 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.
- Catalyst Orthoscience, Inc. (13 510(k)s)
- Catalyst, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Catalyst Research Corp.?
FDA lists 9 510(k) clearances under the applicant name “Catalyst Research Corp.” (first 1978, latest 1991), 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 Catalyst Research Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Catalyst Research Corp. is 37 days.
Which FDA product codes appear under Catalyst Research Corp.?
The most frequent FDA product codes under this applicant name are CCL (Analyzer, Gas, Oxygen, Gaseous-Phase, 4); DQA (Oximeter, 3); BXL (Algesimeter, Manual, 1).
Next steps
- See all 9 Catalyst Research Corp. clearances with predicates and recalls
- Run predicate analysis for product code CCL, Catalyst 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.