Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Arc Surgical, LLC — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
189 daysmedian FDA review time
260 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141559 | V-GUIDE FOR VENTRICULOSTOMIES | Arc Surgical, LLC | 2015-02-27 | 260 | 0 |
| K071616 | ARC SURGICAL BIOTRAK PIN SYSTEM | Arc Surgical, LLC | 2007-12-19 | 189 | 0 |
| K063244 | ARC SURGICAL BONE REDUCTION SCREW | Arc Surgical, LLC | 2006-12-27 | 62 | 0 |
| K061763 | ARC SURGICAL BIOTRAK SCREW | Arc Surgical, LLC | 2006-09-19 | 89 | 1 |
| K043176 | ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM | Arc Surgical, LLC | 2005-06-17 | 213 | 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