Unicare Biomedical, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under 2 spellings of the applicant name “Unicare Biomedical, Inc.” (first 1998, latest 2015), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 83 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 | 1 | 184 |
| 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 |
|---|---|---|---|
| LYC | Bone Grafting Material, Synthetic | 7 | 7 |
| JEY | Plate, Bone | 1 | 1 |
| NPK | Barrier, Synthetic, Intraoral | 1 | 1 |
| OLR | Oral Wound Dressing | 1 | 1 |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | 1 | 1 |
Review panels
- Dental (10)
- General and Plastic Surgery (1)
Most recent Unicare Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151344 | Cytoflex Tefguard Ti-Enforced Membrane | NPK | 2015-11-19 | 184 |
| K092567 | MODIFICATION TO UNIGRAFT | LYC | 2009-11-25 | 97 |
| K090612 | BENACEL | OLR | 2009-07-24 | 140 |
| K090083 | CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090 | LYC | 2009-03-23 | 70 |
| K080532 | BENACEL, MODELS C-001, C-002 AND C-005 | QSY | 2008-11-12 | 260 |
| K021511 | CYTOFLEX MESH | JEY | 2002-08-06 | 89 |
| K020720 | OSSIFORM | LYC | 2002-05-07 | 63 |
| K012144 | CYTOFLEX | LYC | 2001-10-01 | 83 |
| K003457 | UNIGRAFT | LYC | 2001-01-09 | 63 |
| K993784 | UNIGRAFT | LYC | 2000-01-27 | 80 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Unicare Biomedical, 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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Unicare Biomedical, Inc. (7)
- Unicare Biomedical (4)
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.
- Unicare Medical Products, Inc. (1 510(k)s)
- Unicare Systems, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Unicare Biomedical, Inc.?
FDA lists 11 510(k) clearances under 2 spellings of the applicant name “Unicare Biomedical, Inc.” (first 1998, latest 2015), across 5 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 Unicare Biomedical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Unicare Biomedical, Inc. is 83 days.
Which FDA product codes appear under Unicare Biomedical, Inc.?
The most frequent FDA product codes under this applicant name are LYC (Bone Grafting Material, Synthetic, 7); JEY (Plate, Bone, 1); NPK (Barrier, Synthetic, Intraoral, 1).
Next steps
- See all 11 Unicare Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LYC, Unicare Biomedical, 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 (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.