Catalina Biomedical Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Catalina Biomedical Corp.” (first 1990, latest 1992), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 84 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 |
|---|---|---|---|
| MCY | Wound Dressing Kit | 2 | 2 |
| KGX | Tape And Bandage, Adhesive | 1 | 1 |
| KMK | Device, Intravascular Catheter Securement | 1 | 1 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 1 | 1 |
Review panels
Most recent Catalina Biomedical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K920050 | BIOLEX WOUND GEL, | MGQ | 1992-04-07 | 92 |
| K913480 | WOUND CARE TRAY A | MCY | 1991-10-18 | 73 |
| K913479 | WOUND CARE TRAY B | MCY | 1991-10-08 | 63 |
| K896358 | VARI/MOIST WOUND DRESSING | KGX | 1990-02-01 | 87 |
| K896421 | TRANSPARENT FILM I.V. SITE/WOUND DRESSING | KMK | 1990-01-31 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Catalina Biomedical 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.
- Catalina, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Catalina Biomedical Corp.?
FDA lists 5 510(k) clearances under the applicant name “Catalina Biomedical Corp.” (first 1990, latest 1992), across 4 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 Catalina Biomedical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Catalina Biomedical Corp. is 84 days.
Which FDA product codes appear under Catalina Biomedical Corp.?
The most frequent FDA product codes under this applicant name are MCY (Wound Dressing Kit, 2); KGX (Tape And Bandage, Adhesive, 1); KMK (Device, Intravascular Catheter Securement, 1).
Next steps
- See all 5 Catalina Biomedical Corp. clearances with predicates and recalls
- Run predicate analysis for product code MCY, Catalina Biomedical 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.