Aplicare, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Aplicare, Inc.” (first 1983, latest 1994), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 42 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 |
|---|---|---|---|
| LKB | Pad, Alcohol, Device Disinfectant | 4 | 4 |
| NEC | Bandage, Liquid, Skin Protectant | 2 | 2 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 1 | 1 |
| JOL | Catheter And Tip, Suction | 1 | 1 |
| KMF | Bandage, Liquid | 1 | 1 |
Review panels
Most recent Aplicare, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K923299 | APLICARE ONE COMPUND BENZION TINCTURE SWABSTICK | KMF | 1994-01-18 | 561 |
| K895039 | STERILE SALINE - FOR SUCTION CATHETER LUBRICATION | GCX | 1989-10-03 | 55 |
| K873563 | APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY | JOL | 1987-11-23 | 82 |
| K861557 | APLICARE SKIN PROTECTANT PREP PAD | NEC | 1986-07-11 | 77 |
| K861558 | APLICARE SKIN PROTECTANT SWABSTICK | NEC | 1986-06-04 | 40 |
| K833185 | ACETONE ALCOHOL PREP PAD | LKB | 1983-10-31 | 42 |
| K833183 | APLICARE ONE ACETONE ALCOHOL SWABSTICK | LKB | 1983-10-31 | 42 |
| K833184 | APLICARE THREE ALCOHOL SWABSTICKS | LKB | 1983-10-27 | 38 |
| K833182 | APLICARE ALCOHOL PREP PAD | LKB | 1983-10-27 | 38 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2010-03-03.
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 Aplicare, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Aplicare, Inc.” (first 1983, latest 1994), across 5 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 Aplicare, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aplicare, Inc. is 42 days.
Which FDA product codes appear under Aplicare, Inc.?
The most frequent FDA product codes under this applicant name are LKB (Pad, Alcohol, Device Disinfectant, 4); NEC (Bandage, Liquid, Skin Protectant, 2); GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered, 1).
Next steps
- See all 9 Aplicare, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LKB, Aplicare, Inc.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.