Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Oakfield Instruments, Ltd. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
172 daysmedian FDA review time
250 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964804 | FLEXILOG LS | Oakfield Instruments, Ltd. | 1997-08-06 | 250 | 0 |
| K964589 | FLEXILOG 3000 | Oakfield Instruments, Ltd. | 1997-03-04 | 109 | 0 |
| K961895 | FLEXILOG LS 13921 | Oakfield Instruments, Ltd. | 1996-11-04 | 172 | 0 |
| K945069 | FLEXILOG 2000 | Oakfield Instruments, Ltd. | 1995-06-13 | 242 | 0 |
| K920115 | MEDISCINT | Oakfield Instruments, Ltd. | 1992-03-30 | 77 | 0 |
| K902460 | CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR) | Oakfield Instruments, Ltd. | 1990-08-28 | 85 | 0 |
| K896288 | FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM | Oakfield Instruments, Ltd. | 1990-05-04 | 186 | 0 |
| K894902 | SOURCERER | Oakfield Instruments, Ltd. | 1989-10-17 | 77 | 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