Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Jeff Klein Surgical, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
39 daysmedian FDA review time
41 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K901717 | KLEIN MICRO-CANNULA(TM) | Jeff Klein Surgical, Inc. | 1990-05-24 | 41 | 0 |
| K901718 | KLEIN LAMPREY-CANNULA(TM) | Jeff Klein Surgical, Inc. | 1990-05-24 | 41 | 0 |
| K901719 | KLEIN MICRO-CANNULA HANDLE(TM) | Jeff Klein Surgical, Inc. | 1990-05-22 | 39 | 0 |
| K901716 | KLEIN CONNECTOR(TM) | Jeff Klein Surgical, Inc. | 1990-05-11 | 28 | 0 |
| K901715 | KLEIN CORK(TM) | Jeff Klein Surgical, Inc. | 1990-05-11 | 28 | 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