Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ocean Medical Products, Ltd. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
27 daysmedian FDA review time
80 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K882013 | SOFT TISSUE BIOPSY DEVICE | Ocean Medical Products, Ltd. | 1988-06-15 | 33 | 0 |
| K870896 | NOTCH-NEEDLE, WESCOTT STYLE | Ocean Medical Products, Ltd. | 1987-03-18 | 13 | 0 |
| K843719 | SINGLE WALL INTRODUCER NEEDLE | Ocean Medical Products, Ltd. | 1984-10-18 | 24 | 0 |
| K823693 | MYELOGRAPHY NEEDLE | Ocean Medical Products, Ltd. | 1983-02-07 | 61 | 0 |
| K823692 | SPINAL NEEDLE | Ocean Medical Products, Ltd. | 1983-01-07 | 30 | 0 |
| K813462 | MADAYAG TYPE NEEDLE | Ocean Medical Products, Ltd. | 1982-03-01 | 80 | 2 |
| K813448 | POTTS-COURNAND STYLE NEEDLE | Ocean Medical Products, Ltd. | 1982-01-07 | 27 | 0 |
| K813460 | CHIBA SKINNY NEEDLE | Ocean Medical Products, Ltd. | 1982-01-07 | 27 | 0 |
| K813461 | PERCUTANEOUS ENTRY NEEDLE, SELDINGER | Ocean Medical Products, Ltd. | 1981-12-29 | 18 | 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