Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Health Care Mfg., Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
245 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022667 | HCMI X-RAY | Health Care Mfg., Inc. | 2002-10-22 | 71 | 0 |
| K022737 | HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC | Health Care Mfg., Inc. | 2002-10-22 | 64 | 1 |
| K952441 | LEGEND | Health Care Mfg., Inc. | 1995-06-19 | 25 | 0 |
| K951323 | VH-2000 | Health Care Mfg., Inc. | 1995-06-07 | 76 | 0 |
| K951382 | HLT 406 | Health Care Mfg., Inc. | 1995-06-01 | 66 | 0 |
| K944699 | ATT-300 | Health Care Mfg., Inc. | 1995-05-26 | 245 | 0 |
| K944329 | BACK SPECIALIST | Health Care Mfg., Inc. | 1995-03-15 | 190 | 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