Ulster Scientific, Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Ulster Scientific, Inc.” (first 1980, latest 1994), across 12 product codes in 5 review panels. Median 510(k) review time under this name: 48 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 |
|---|---|---|---|
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 4 | 4 |
| FMF | Syringe, Piston | 3 | 3 |
| JPH | Test, Erythrocyte Sedimentation Rate | 3 | 3 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 2 | 2 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| FML | Chair, Blood Donor | 1 | 1 |
| GKJ | Spinner, Slide, Automated | 1 | 1 |
| GXB | Esthesiometer | 1 | 1 |
| JCA | Device, Bleeding Time | 1 | 1 |
| KZE | Injector, Fluid, Non-Electrically Powered | 1 | 1 |
Plus 2 more product codes.
Review panels
- Hematology (6)
- General Hospital (6)
- General and Plastic Surgery (4)
- Clinical Chemistry (3)
- Neurology (1)
Most recent Ulster Scientific, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942620 | FEATHER-TOUCH SINGLE-STICK DEVICE | FMK | 1994-06-22 | 20 |
| K920562 | UNISTIK | FMK | 1992-03-27 | 50 |
| K902592 | EPC ELECTRONIC PIPETTING SYSTEM | JQW | 1990-07-19 | 37 |
| K895890 | AUTOPEN | FMF | 1990-02-16 | 134 |
| K894474 | THE AUTOLET LITE | FMK | 1989-08-18 | 31 |
| K885340 | AIR DISPLACEMENT PIPETTE | JQW | 1989-02-14 | 48 |
| K875354 | UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM | LCP | 1988-02-17 | 48 |
| K871571 | NEUROTIPS(TM) | GXB | 1987-06-18 | 57 |
| K871076 | WINPETTE | JPH | 1987-03-23 | 5 |
| K870078 | ACCUPEN(R) | FMF | 1987-03-17 | 68 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ulster Scientific, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ulster Scientific, Inc.?
FDA lists 20 510(k) clearances under the applicant name “Ulster Scientific, Inc.” (first 1980, latest 1994), across 12 product codes in 5 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 Ulster Scientific, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ulster Scientific, Inc. is 48 days.
Which FDA product codes appear under Ulster Scientific, Inc.?
The most frequent FDA product codes under this applicant name are FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature, 4); FMF (Syringe, Piston, 3); JPH (Test, Erythrocyte Sedimentation Rate, 3).
Next steps
- See all 20 Ulster Scientific, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMK, Ulster Scientific, 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.