Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Oxford Instruments Medical Systems · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
263 daysmedian FDA review time
633 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992607 | SONICAID SYSTEM 8002 | Oxford Instruments Medical Systems | 2001-04-27 | 633 | 0 |
| K984052 | SYNERGY IOM SYSTEM | Oxford Instruments Medical Systems | 1999-05-17 | 185 | 0 |
| K970902 | MEDILOG FD4 | Oxford Instruments Medical Systems | 1997-05-05 | 55 | 0 |
| K961638 | MEDILOG MPA-S | Oxford Instruments Medical Systems | 1997-01-17 | 263 | 0 |
| K943862 | SONICAID MODEL MR-63 AMBULATORY ECG RECORDER | Oxford Instruments Medical Systems | 1995-06-07 | 303 | 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