Aplicare, Inc.
Mchenry, IL, US
Aplicare, Inc. appears in FDA device records in Mchenry, IL. FDA records list 9 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Aplicare, Inc. between 1983 and 1994. The busiest year on record is 1983, with 4. The most recent is 1994, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 4 |
| 1986 | 2 |
| 1987 | 1 |
| 1989 | 1 |
| 1994 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K923299 | APLICARE ONE COMPUND BENZION TINCTURE SWABSTICK | KMF | Substantially Equivalent | |
| K895039 | STERILE SALINE - FOR SUCTION CATHETER LUBRICATION | GCX | Substantially Equivalent | |
| K873563 | APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY | JOL | Substantially Equivalent | |
| K861557 | APLICARE SKIN PROTECTANT PREP PAD | NEC | Substantially Equivalent | |
| K861558 | APLICARE SKIN PROTECTANT SWABSTICK | NEC | Substantially Equivalent | |
| K833185 | ACETONE ALCOHOL PREP PAD | LKB | Substantially Equivalent | |
| K833183 | APLICARE ONE ACETONE ALCOHOL SWABSTICK | LKB | Substantially Equivalent | |
| K833184 | APLICARE THREE ALCOHOL SWABSTICKS | LKB | Substantially Equivalent | |
| K833182 | APLICARE ALCOHOL PREP PAD | LKB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1310-2010 | Aplicare Advantage Dressing Change System, Central Line Dressing Change, Sterile Part number: A3402. The product is used for Central Line Dressing Change. | Incorrect expiration date on outer kit label-extended. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain