Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sharpoint, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
32 daysmedian FDA review time
88 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K863595 | COATED SUTURE NEEDLE | Sharpoint, Inc. | 1986-10-24 | 39 | 0 |
| K861947 | SURGICAL KNIFE | Sharpoint, Inc. | 1986-06-06 | 17 | 0 |
| K840764 | EAR KNIVES | Sharpoint, Inc. | 1984-05-21 | 88 | 0 |
| K840855 | CORNEAL SCLERAL LANCE | Sharpoint, Inc. | 1984-05-09 | 75 | 0 |
| K840660 | POSTERIOR CAPSULOTOMY CYSTITOME | Sharpoint, Inc. | 1984-03-16 | 30 | 0 |
| K840659 | ANTERIOR CAPSULECTOMY CYSTITOME | Sharpoint, Inc. | 1984-03-16 | 30 | 0 |
| K830522 | STAINLESS STEEL SUTURE 316L | Sharpoint, Inc. | 1983-03-31 | 42 | 0 |
| K822112 | OPHTHALMIC KNIFE | Sharpoint, Inc. | 1982-08-10 | 22 | 9 |
| K821440 | V LANCE | Sharpoint, Inc. | 1982-06-14 | 32 | 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