Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Heart Technology Mfg., Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K960379 | ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL R | Heart Technology Mfg., Inc. | 1996-04-25 | 90 | 0 |
| K954604 | ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S | Heart Technology Mfg., Inc. | 1996-01-18 | 106 | 0 |
| K953997 | ROTABLATOR ROTATIONAL ANGIOPLASTY | Heart Technology Mfg., Inc. | 1995-12-22 | 120 | 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