Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Halt Medical, Inc. — 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) |
|---|---|---|---|---|---|
| K132744 | ACESSA GUIDANCE SYSTEM | Halt Medical, Inc. | 2014-05-27 | 266 | 0 |
| K132184 | ACESSA GUIDANCE HANDPIECE | Halt Medical, Inc. | 2014-04-28 | 287 | 0 |
| K121858 | THE ABLATION SYSTEM | Halt Medical, Inc. | 2012-11-05 | 132 | 0 |
| K094009 | HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 20 | Halt Medical, Inc. | 2010-06-14 | 168 | 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