Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OCV — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
91 daysmedian FDA review time
486 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240506 | KARL STORZ Holders | Karl Storz Endoscopy America, Inc. | 2024-10-22 | 244 | 0 |
| K232405 | ENDOFIX EXO | Aktormed GmbH | 2024-04-25 | 259 | 0 |
| K190576 | WalterLorenz Surgical Assist Arm Scope Holder | Biomet Microfixation | 2019-06-05 | 91 | 0 |
| K102179 | ENVIEW (TM) | Carefusion 2200 | 2010-12-02 | 121 | 0 |
| K093616 | V. MUELLER CAMERA CONTROLLER WITH STORAGE CART | Carefusion 2200 | 2009-12-23 | 34 | 0 |
| K992006 | NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33 | Integra Neurocare, LLC | 1999-08-17 | 63 | 0 |
| K990334 | KSEA ENDOSCOPE HOLDER | KARL STORZ Endoscopy-America, Inc. | 1999-03-22 | 47 | 0 |
| K971584 | CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERI | Clarus Medical Systems, Inc. | 1997-05-23 | 23 | 0 |
| K960068 | SH-1 SURGICAL HOLDER FOR TELESCOPE | Olympus America, Inc. | 1997-05-05 | 486 | 0 |
| K810787 | UROLOGIC TUBE HOLDER | The Urology Group | 1981-03-31 | 8 | 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