Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ulster Scientific, Inc. · Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
134 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K942620 | FEATHER-TOUCH SINGLE-STICK DEVICE | Ulster Scientific, Inc. | 1994-06-22 | 20 | 0 |
| K920562 | UNISTIK | Ulster Scientific, Inc. | 1992-03-27 | 50 | 0 |
| K902592 | EPC ELECTRONIC PIPETTING SYSTEM | Ulster Scientific, Inc. | 1990-07-19 | 37 | 0 |
| K895890 | AUTOPEN | Ulster Scientific, Inc. | 1990-02-16 | 134 | 0 |
| K894474 | THE AUTOLET LITE | Ulster Scientific, Inc. | 1989-08-18 | 31 | 0 |
| K885340 | AIR DISPLACEMENT PIPETTE | Ulster Scientific, Inc. | 1989-02-14 | 48 | 0 |
| K875354 | UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM | Ulster Scientific, Inc. | 1988-02-17 | 48 | 0 |
| K871571 | NEUROTIPS(TM) | Ulster Scientific, Inc. | 1987-06-18 | 57 | 0 |
| K871076 | WINPETTE | Ulster Scientific, Inc. | 1987-03-23 | 5 | 0 |
| K870078 | ACCUPEN(R) | Ulster Scientific, Inc. | 1987-03-17 | 68 | 0 |
| K864761 | USI AUTOJECT INSULIN SYRINGE | Ulster Scientific, Inc. | 1986-12-16 | 11 | 0 |
| K861243 | NEONATAL UNILET | Ulster Scientific, Inc. | 1986-04-29 | 27 | 0 |
| K860899 | DISPETTE II | Ulster Scientific, Inc. | 1986-04-14 | 35 | 0 |
| K860284 | DIAMATIC, AUTOMATIC INSULIN INJECTOR | Ulster Scientific, Inc. | 1986-04-07 | 69 | 0 |
| K854962 | MICRO-MAT SYSTEM | Ulster Scientific, Inc. | 1985-12-23 | 12 | 0 |
| K851181 | PRECI-JET 50 | Ulster Scientific, Inc. | 1985-06-06 | 73 | 0 |
| K842517 | UNILET LANCET | Ulster Scientific, Inc. | 1984-09-20 | 72 | 0 |
| K831194 | GLUCOKEY | Ulster Scientific, Inc. | 1983-10-31 | 202 | 0 |
| K831195 | WESTERGREN DISPETTE FOR ESR | Ulster Scientific, Inc. | 1983-05-09 | 27 | 0 |
| K801815 | AUTOLET | Ulster Scientific, Inc. | 1980-10-10 | 72 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda