Health Care Innovations, Inc.: FDA clearances and approvals
Health Care Innovations, Inc. has 5 FDA 510(k) clearances (first 1987, latest 1988), across 4 product codes in 3 review panels. Median 510(k) review time: 35 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | 2 | 2 |
| FRW | Scale, Patient | 1 | 1 |
| GBS | Catheter, Ventricular, General & Plastic Surgery | 1 | 1 |
| KGZ | Accessories, Catheter | 1 | 1 |
Review panels
Most recent Health Care Innovations, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K881452 | FOLDING WHEELCHAIR | IOR | 1988-04-21 | 15 |
| K872524 | SAFEWEIGH MAGIC SCALE | FRW | 1987-10-09 | 106 |
| K872940 | FOLDING WHEELCHAIR | IOR | 1987-08-04 | 8 |
| K870015 | HCI ALL PURPOSE DRAIN/CATHETER SET | GBS | 1987-02-06 | 35 |
| K870014 | HCI GENERAL PURPOSE CATHETER STYLET | KGZ | 1987-02-06 | 35 |
Recalls
openFDA lists no recalls under a recalling firm named Health Care Innovations, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Health Care Innovations, Inc. have?
Health Care Innovations, Inc. has 5 FDA 510(k) clearances (first 1987, latest 1988), across 4 product codes in 3 review panels.
How long does FDA take to clear Health Care Innovations, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Health Care Innovations, Inc.'s cleared 510(k)s is 35 days.
What devices does Health Care Innovations, Inc. make?
Its most frequent FDA product codes are IOR (Wheelchair, Mechanical, 2); FRW (Scale, Patient, 1); GBS (Catheter, Ventricular, General & Plastic Surgery, 1).
Has Health Care Innovations, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Health Care Innovations, Inc. Related entities may recall under other names.
Next steps
- See all 5 Health Care Innovations, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IOR, Health Care Innovations, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.