Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Skil-Care Corp. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
34 daysmedian FDA review time
66 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K010818 | INFANT LIMB HOLDER, MODELS 306080 & 306081 | Skil-Care Corp. | 2001-05-24 | 66 | 0 |
| K010644 | CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 | Skil-Care Corp. | 2001-05-18 | 74 | 0 |
| K963458 | PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS | Skil-Care Corp. | 1996-10-18 | 45 | 0 |
| K963459 | SUPPORT VEST | Skil-Care Corp. | 1996-10-15 | 42 | 0 |
| K963461 | SAFETY PONCHO/SHOULDER STRAP PONCHO | Skil-Care Corp. | 1996-10-11 | 38 | 0 |
| K963460 | ROLL BELT | Skil-Care Corp. | 1996-10-09 | 36 | 0 |
| K963457 | SLEEPER JACKET/HOUDINI SAFETY SLEEPER | Skil-Care Corp. | 1996-10-09 | 36 | 0 |
| K963455 | SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROL | Skil-Care Corp. | 1996-10-08 | 35 | 0 |
| K963456 | LIMB HOLDERS-REUSABLE/LIMB HOLDERS-DISPOSABLE/QUICK-CUFF LIM | Skil-Care Corp. | 1996-10-08 | 35 | 0 |
| K963449 | PELVIC HOLDER | Skil-Care Corp. | 1996-10-07 | 34 | 0 |
| K963450 | SAFETY VEST/SHOULDER STRAP VEST/ECONOMY SAFETY VEST | Skil-Care Corp. | 1996-10-07 | 34 | 0 |
| K963448 | ECONO BELT | Skil-Care Corp. | 1996-10-07 | 34 | 0 |
| K963447 | DOUBLE SUPPORT PONCHO/SLIDER PONCHO | Skil-Care Corp. | 1996-10-07 | 34 | 0 |
| K963454 | CUSHION BELT/CUSHION SLIDER BELT/ADJUSTA-LOOP CUSHION BELT/Q | Skil-Care Corp. | 1996-10-07 | 34 | 0 |
| K801489 | EZ ON SAFETY PONCHO | Skil-Care Corp. | 1980-07-14 | 18 | 0 |
| K801217 | SKIL-CARE GEL WEDGE, FLOTATION PAD | Skil-Care Corp. | 1980-05-30 | 9 | 0 |
| K800208 | SKIL-CARE LEG PADS | Skil-Care Corp. | 1980-02-21 | 20 | 0 |
| K792318 | SKIL-CARE TURN AND HOLD PAD | Skil-Care Corp. | 1979-12-20 | 31 | 0 |
| K791993 | SKIL-CARE BED RAIL PADS | Skil-Care Corp. | 1979-10-26 | 23 | 0 |
| K792012 | SKIL-CARE SUPER-SOFT LIMB RESTRAINTS | Skil-Care Corp. | 1979-10-26 | 21 | 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