Support Systems Intl.: FDA clearances and approvals
Support Systems Intl. has 5 FDA 510(k) clearances (first 1992, latest 1995), across 2 product codes in 1 review panel. Median 510(k) review time: 68 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 |
|---|---|---|---|
| IOQ | Bed, Flotation Therapy, Powered | 4 | 4 |
| INX | Bed, Air Fluidized | 1 | 1 |
Review panels
Most recent Support Systems Intl. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K941610 | CLENSICAIR LOW AIRLOSS HYDROTHERAPY | IOQ | 1995-02-10 | 316 |
| K940662 | I-5000 | IOQ | 1994-06-15 | 117 |
| K922973 | RESTCUE CC | IOQ | 1992-07-30 | 38 |
| K920382 | FLEXICAIR LOW AIRLOSS THERAPY UNIT | IOQ | 1992-04-07 | 68 |
| K920112 | CLINITRON C-II | INX | 1992-01-24 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Support Systems Intl..
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 Support Systems Intl. have?
Support Systems Intl. has 5 FDA 510(k) clearances (first 1992, latest 1995), across 2 product codes in 1 review panel.
How long does FDA take to clear Support Systems Intl.'s 510(k)s?
The median time from FDA receipt to decision across Support Systems Intl.'s cleared 510(k)s is 68 days.
What devices does Support Systems Intl. make?
Its most frequent FDA product codes are IOQ (Bed, Flotation Therapy, Powered, 4); INX (Bed, Air Fluidized, 1).
Has Support Systems Intl. had device recalls?
openFDA lists no recalls under a recalling firm name matching Support Systems Intl. Related entities may recall under other names.
Next steps
- See all 5 Support Systems Intl. clearances with predicates and recalls
- Run predicate analysis for product code IOQ, Support Systems Intl.'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.