Raven Biological Laboratories, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Raven Biological Laboratories, Inc.” (first 1992, latest 2009), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 91 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 |
|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | 12 | 12 |
| MRB | Indicator, Biological, Liquid Chemical Sterilization Process | 2 | 2 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 1 | 1 |
Review panels
- General Hospital (15)
Most recent Raven Biological Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082756 | RAVEN PROTEST - STEAM BIOLOGICAL INDICATOR | FRC | 2009-10-21 | 397 |
| K062651 | PROCHEM EXT CHEMICAL INTEGRATOR | JOJ | 2007-03-15 | 189 |
| K053212 | RAVEN PROPACT | MRB | 2006-02-15 | 91 |
| K050591 | MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS | FRC | 2005-03-23 | 15 |
| K041784 | RAVEN PROTEST - EO | FRC | 2004-09-13 | 74 |
| K041386 | RAVEN PROTEST - STEAM | FRC | 2004-08-09 | 76 |
| K032914 | MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS | FRC | 2004-05-25 | 246 |
| K031114 | PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA | MRB | 2004-03-03 | 330 |
| K020026 | RAVEN BACTERIAL SPORE STRIPS | FRC | 2002-01-30 | 26 |
| K994381 | PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR | FRC | 2001-03-30 | 458 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Raven Biological Laboratories, 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.
- Raven Eye, Inc. (2 510(k)s)
- Raven Laboratories (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Raven Biological Laboratories, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Raven Biological Laboratories, Inc.” (first 1992, latest 2009), across 3 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 Raven Biological Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Raven Biological Laboratories, Inc. is 91 days.
Which FDA product codes appear under Raven Biological Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are FRC (Indicator, Biological Sterilization Process, 12); MRB (Indicator, Biological, Liquid Chemical Sterilization Process, 2); JOJ (Indicator, Physical/Chemical Sterilization Process, 1).
Next steps
- See all 15 Raven Biological Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRC, Raven Biological Laboratories, 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.