Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tools For Surgery, LLC — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242901 | ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr | Tools For Surgery, LLC | 2025-01-10 | 109 | 0 |
| K220218 | Siren SGT | Tools For Surgery, LLC | 2022-05-18 | 112 | 0 |
| K040109 | HEMORRHAGE OCCLUDER PIN | Tools For Surgery, LLC | 2004-03-25 | 65 | 0 |
| K040110 | EASY LOOP, MODEL EZL-01 | Tools For Surgery, LLC | 2004-03-24 | 64 | 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