Sinclair Pharmaceuticals, Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under 2 spellings of the applicant name “Sinclair Pharmaceuticals, Ltd.” (first 2001, latest 2006), plus 1 De Novo decision, across 6 product codes in 3 review panels. Median 510(k) review time under this name: 104 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 |
|---|---|---|---|
| OLR | Oral Wound Dressing | 4 | 4 |
| NTO | Rinse, Oral, Antibacterial (By Physical Means) | 2 | 1 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| LED | Stains, Chemical Solution | 1 | 1 |
| LFD | Saliva, Artificial | 1 | 1 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 1 | 1 |
Review panels
- Dental (7)
- General and Plastic Surgery (2)
- Pathology (1)
Most recent Sinclair Pharmaceuticals, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050158 | SINCLAIR SEBORRHEA EMULSION | FRO | 2006-10-11 | 624 |
| K053166 | SINCLAIR ORAL RINSE | NTO | 2006-05-17 | 184 |
| K042722 | ALOCLAIR ORAL SPRAY | OLR | 2005-01-13 | 104 |
| K040950 | ALOCLAIR ORAL GEL | OLR | 2004-06-21 | 70 |
| K024148 | SALINUM, ORCLAIR | LFD | 2003-09-15 | 273 |
| K024367 | SINCLAIR WOUND AND SKIN EMULSION | MGQ | 2003-07-28 | 209 |
| K023046 | SST SALIVA SUPPORTING TABLETS | LED | 2002-12-02 | 81 |
| K023155 | ALOCLAIR ORAL RINSE | OLR | 2002-11-25 | 63 |
| K013056 | GELCLAIR CONCENTRATED ORAL GEL | OLR | 2001-12-21 | 101 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN050001 | De Novo | Rinse, Oral, Antibacterial (By Physical Means) | 2005-04-18 |
Recalls
openFDA lists no recalls under a recalling firm named Sinclair Pharmaceuticals, Ltd..
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:
- Sinclair Pharmaceuticals, Ltd. (8)
- Sinclair Pharmaceuticals Limited (2)
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.
- Sinclair Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sinclair Pharmaceuticals, Ltd.?
FDA lists 9 510(k) clearances under 2 spellings of the applicant name “Sinclair Pharmaceuticals, Ltd.” (first 2001, latest 2006), plus 1 De Novo decision, across 6 product codes in 3 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 Sinclair Pharmaceuticals, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sinclair Pharmaceuticals, Ltd. is 104 days.
Which FDA product codes appear under Sinclair Pharmaceuticals, Ltd.?
The most frequent FDA product codes under this applicant name are OLR (Oral Wound Dressing, 4); NTO (Rinse, Oral, Antibacterial (By Physical Means), 2); FRO (Dressing, Wound, Drug, 1).
Next steps
- See all 9 Sinclair Pharmaceuticals, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code OLR, Sinclair Pharmaceuticals, Ltd.'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.