Ssi Medical Services, Inc.: FDA clearances and approvals
Ssi Medical Services, Inc. has 6 FDA 510(k) clearances (first 1986, latest 1995), across 4 product codes in 3 review panels. Median 510(k) review time: 95 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 |
|---|---|---|---|
| INX | Bed, Air Fluidized | 3 | 3 |
| FNM | Mattress, Air Flotation, Alternating Pressure | 1 | 1 |
| IOQ | Bed, Flotation Therapy, Powered | 1 | 1 |
| IXQ | Table, Radiographic, Stationary Top | 1 | 1 |
Review panels
- Physical Medicine (4)
- General Hospital (1)
- Radiology (1)
Most recent Ssi Medical Services, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K943385 | CLINITRON ELEXIS | INX | 1995-02-27 | 229 |
| K942184 | CLINITRON AT HOME AIR FLUIDED THERAPY | INX | 1995-02-07 | 279 |
| K914351 | CLINITRON C-10 | IXQ | 1992-02-14 | 140 |
| K890523 | SUPERCAIR | INX | 1989-02-10 | 8 |
| K882161 | ACUCAIR CUSHION CONTINUOUS AIRFLOW SYSTEM | FNM | 1988-07-12 | 50 |
| K863047 | FLEXICAIR | IOQ | 1986-09-05 | 24 |
Recalls
openFDA lists no recalls under a recalling firm named Ssi Medical Services, 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 Ssi Medical Services, Inc. have?
Ssi Medical Services, Inc. has 6 FDA 510(k) clearances (first 1986, latest 1995), across 4 product codes in 3 review panels.
How long does FDA take to clear Ssi Medical Services, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Ssi Medical Services, Inc.'s cleared 510(k)s is 95 days.
What devices does Ssi Medical Services, Inc. make?
Its most frequent FDA product codes are INX (Bed, Air Fluidized, 3); FNM (Mattress, Air Flotation, Alternating Pressure, 1); IOQ (Bed, Flotation Therapy, Powered, 1).
Has Ssi Medical Services, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Ssi Medical Services, Inc. Related entities may recall under other names.
Next steps
- See all 6 Ssi Medical Services, Inc. clearances with predicates and recalls
- Run predicate analysis for product code INX, Ssi Medical Services, 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.