Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Health Care Innovations, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
35 daysmedian FDA review time
106 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K881452 | FOLDING WHEELCHAIR | Health Care Innovations, Inc. | 1988-04-21 | 15 | 0 |
| K872524 | SAFEWEIGH MAGIC SCALE | Health Care Innovations, Inc. | 1987-10-09 | 106 | 0 |
| K872940 | FOLDING WHEELCHAIR | Health Care Innovations, Inc. | 1987-08-04 | 8 | 0 |
| K870014 | HCI GENERAL PURPOSE CATHETER STYLET | Health Care Innovations, Inc. | 1987-02-06 | 35 | 0 |
| K870015 | HCI ALL PURPOSE DRAIN/CATHETER SET | Health Care Innovations, Inc. | 1987-02-06 | 35 | 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