Sage Biopharma: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Sage Biopharma” (first 1999, latest 2000), across 1 product code in 1 review panel. Median 510(k) review time under this name: 214 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 |
|---|---|---|---|
| MQL | Media, Reproductive | 6 | 6 |
Review panels
Most recent Sage Biopharma 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003734 | SERUM PROTEIN SUBSTITUTE | MQL | 2000-12-21 | 17 |
| K002836 | MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE | MQL | 2000-10-03 | 21 |
| K991396 | WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L | MQL | 2000-02-15 | 300 |
| K991393 | HYALURONIDASE, 80 U/ML | MQL | 2000-02-02 | 287 |
| K991390 | 1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI | MQL | 2000-01-18 | 272 |
| K991378 | PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL RED | MQL | 1999-09-24 | 156 |
Recalls
openFDA lists no recalls under a recalling firm named Sage Biopharma.
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.
- Sage Products, Inc. (31 510(k)s)
- Sage In-Vitro Fertilization, Inc. (2 510(k)s)
- Sage Pharmaceuticals, Inc. (2 510(k)s)
- Sage Electronics Products, Inc. (1 510(k)s)
- Sage Laboratories, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sage Biopharma?
FDA lists 6 510(k) clearances under the applicant name “Sage Biopharma” (first 1999, latest 2000), across 1 product code 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 Sage Biopharma?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sage Biopharma is 214 days.
Which FDA product codes appear under Sage Biopharma?
The most frequent FDA product codes under this applicant name are MQL (Media, Reproductive, 6).
Next steps
- See all 6 Sage Biopharma clearances with predicates and recalls
- Run predicate analysis for product code MQL, Sage Biopharma'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.