Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Helix Medical, 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) |
|---|---|---|---|---|---|
| K130736 | BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS | Helix Medical, LLC | 2013-12-17 | 274 | 0 |
| K131745 | BLOM-SINGER SEPTAL PERFORATION PROSTHESIS | Helix Medical, LLC | 2013-09-17 | 96 | 0 |
| K093258 | BLOM-SINGER INDWELLING TEP OCCLUDER | Helix Medical, LLC | 2010-03-03 | 135 | 0 |
| K082206 | BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS D | Helix Medical, LLC | 2008-09-04 | 30 | 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