Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Oxford Instruments, Plc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
263 daysmedian FDA review time
924 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K981405 | SYNERGY LT | Oxford Instruments, Plc. | 1998-07-16 | 87 | 0 |
| K961642 | MEDILOG MR95 | Oxford Instruments, Plc. | 1997-01-17 | 263 | 0 |
| K961636 | MEDILOG VISION | Oxford Instruments, Plc. | 1997-01-17 | 263 | 0 |
| K930714 | SONICAID MODEL TEAM FECG IUP | Oxford Instruments, Plc. | 1995-08-24 | 924 | 0 |
| K933816 | SONICAID MODEL P110 FETAL HEAR DETECTOR | Oxford Instruments, Plc. | 1994-12-22 | 505 | 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