Cytophil, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Cytophil, Inc.” (first 2008, latest 2015), across 4 product codes in 4 review panels. Median 510(k) review time under this name: 144 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 | 1 | 248 |
| 2014 | 0 | — |
| 2015 | 1 | 47 |
| 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 |
|---|---|---|---|
| MIX | System, Vocal Cord Medialization | 4 | 4 |
| LYC | Bone Grafting Material, Synthetic | 2 | 2 |
| MQV | Filler, Bone Void, Calcium Compound | 1 | 1 |
| NEU | Marker, Radiographic, Implantable | 1 | 1 |
Review panels
- Ear, Nose and Throat (4)
- Dental (2)
- Orthopedic (1)
- General and Plastic Surgery (1)
Most recent Cytophil, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150400 | Renu Gel | MIX | 2015-04-06 | 47 |
| K121795 | CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT | MIX | 2013-02-22 | 248 |
| K102937 | OSTEOPHIL BETA-TCP | MQV | 2010-12-27 | 84 |
| K093871 | PERIOPHIL B-TCP | LYC | 2010-04-22 | 126 |
| K092788 | PERIOPHIL BIPHASIC | LYC | 2009-12-18 | 99 |
| K081816 | VOCALIS AND VOCALIS SM | MIX | 2009-01-05 | 193 |
| K081815 | VOCALIS GEL | MIX | 2009-01-05 | 193 |
| K072219 | CYTOPHIL TISSUE MARKER | NEU | 2008-01-18 | 161 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2012-01-11.
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 Cytophil, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Cytophil, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Cytophil, Inc.” (first 2008, latest 2015), across 4 product codes in 4 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 Cytophil, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cytophil, Inc. is 144 days.
Which FDA product codes appear under Cytophil, Inc.?
The most frequent FDA product codes under this applicant name are MIX (System, Vocal Cord Medialization, 4); LYC (Bone Grafting Material, Synthetic, 2); MQV (Filler, Bone Void, Calcium Compound, 1).
Next steps
- See all 8 Cytophil, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MIX, Cytophil, 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.