A.P. Total Care, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “A.P. Total Care, Inc.” (first 1999, latest 1999), across 16 product codes in 2 review panels. Median 510(k) review time under this name: 62 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 |
|---|---|---|---|
| JMO | Ferrozine (Colorimetric) Iron Binding Capacity | 2 | 2 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 2 | 2 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CFR | Hexokinase, Glucose | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| CGZ | Electrode, Ion-Specific, Chloride | 1 | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 | 1 |
Plus 6 more product codes.
Review panels
- Clinical Chemistry (17)
- Hematology (1)
Most recent A.P. Total Care, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K991246 | FRUCTOSAMINE, MODEL FR 106-01 | LCP | 1999-12-16 | 248 |
| K991762 | ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 | CJE | 1999-09-02 | 101 |
| K991761 | MAGNESIUM PRODUCT NO'S, 112-01, 112-02 | JGJ | 1999-09-02 | 101 |
| K991664 | LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01 | LBS | 1999-08-19 | 97 |
| K991665 | HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01 | LBS | 1999-08-10 | 88 |
| K991867 | INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 | CEO | 1999-08-02 | 62 |
| K991866 | BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04 | CIG | 1999-08-02 | 62 |
| K991870 | ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03 | CGZ | 1999-07-30 | 59 |
| K991666 | TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 | JMO | 1999-06-30 | 47 |
| K991663 | AST/SGOT | CIT | 1999-06-30 | 47 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named A.P. Total Care, Inc..
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 A.P. Total Care, Inc.?
FDA lists 18 510(k) clearances under the applicant name “A.P. Total Care, Inc.” (first 1999, latest 1999), across 16 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 A.P. Total Care, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name A.P. Total Care, Inc. is 62 days.
Which FDA product codes appear under A.P. Total Care, Inc.?
The most frequent FDA product codes under this applicant name are JMO (Ferrozine (Colorimetric) Iron Binding Capacity, 2); LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl, 2); CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen, 1).
Next steps
- See all 18 A.P. Total Care, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JMO, A.P. Total Care, 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.