Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Scholten Surgical Instruments, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
427 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K072051 | NOVATOME, MODEL: SU101-50 | Scholten Surgical Instruments, Inc. | 2007-10-03 | 69 | 0 |
| K900405 | SCHOLTEN FRAME | Scholten Surgical Instruments, Inc. | 1990-03-01 | 31 | 0 |
| K852331 | SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC | Scholten Surgical Instruments, Inc. | 1986-08-01 | 427 | 0 |
| K852119 | TEMPORARY PACEMAKER GROUND WIRE | Scholten Surgical Instruments, Inc. | 1985-09-15 | 123 | 0 |
| K852332 | TABLE ACCESSORIES, OPERATING ROOM | Scholten Surgical Instruments, Inc. | 1985-07-02 | 32 | 0 |
| K852120 | FORCEPS, BIOPSY(NON RIGID) | Scholten Surgical Instruments, Inc. | 1985-07-02 | 48 | 0 |
| K852330 | RETRACTOR, SURGICAL | Scholten Surgical Instruments, Inc. | 1985-06-27 | 27 | 0 |
| K852329 | STAND, OPERATING ROOM | Scholten Surgical Instruments, Inc. | 1985-06-14 | 14 | 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