Skil-Care Corp.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Skil-Care Corp.” (first 1979, latest 2001), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 34 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| FMQ | Restraint, Protective | 12 | 12 |
| KID | Restraint, Wheelchair, Non-Protective | 3 | 3 |
| KNO | Accessories, Wheelchair | 2 | 2 |
| FMR | Device, Transfer, Patient, Manual | 1 | 1 |
| FNJ | Bed, Manual | 1 | 1 |
| KIC | Cushion, Flotation | 1 | 1 |
Review panels
- General Hospital (14)
- Physical Medicine (6)
Most recent Skil-Care Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K010818 | INFANT LIMB HOLDER, MODELS 306080 & 306081 | FMQ | 2001-05-24 | 66 |
| K010644 | CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 | FMQ | 2001-05-18 | 74 |
| K963458 | PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM PADDED MITTS | FMQ | 1996-10-18 | 45 |
| K963459 | SUPPORT VEST | KID | 1996-10-15 | 42 |
| K963461 | SAFETY PONCHO/SHOULDER STRAP PONCHO | KID | 1996-10-11 | 38 |
| K963460 | ROLL BELT | FMQ | 1996-10-09 | 36 |
| K963457 | SLEEPER JACKET/HOUDINI SAFETY SLEEPER | FMQ | 1996-10-09 | 36 |
| K963456 | LIMB HOLDERS-REUSABLE/LIMB HOLDERS-DISPOSABLE/QUICK-CUFF LIMB HOLDER | FMQ | 1996-10-08 | 35 |
| K963455 | SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROL | KID | 1996-10-08 | 35 |
| K963454 | CUSHION BELT/CUSHION SLIDER BELT/ADJUSTA-LOOP CUSHION BELT/QUICK RELEASE CUSHION BELT | FMQ | 1996-10-07 | 34 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Skil-Care Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Skil-Care Corp.?
FDA lists 20 510(k) clearances under the applicant name “Skil-Care Corp.” (first 1979, latest 2001), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Skil-Care Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Skil-Care Corp. is 34 days.
Which FDA product codes appear under Skil-Care Corp.?
The most frequent FDA product codes under this applicant name are FMQ (Restraint, Protective, 12); KID (Restraint, Wheelchair, Non-Protective, 3); KNO (Accessories, Wheelchair, 2).
Next steps
- See all 20 Skil-Care Corp. clearances with predicates and recalls
- Run predicate analysis for product code FMQ, Skil-Care Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.