Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
A.P. Total Care, Inc. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
101 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K991246 | FRUCTOSAMINE, MODEL FR 106-01 | A.P. Total Care, Inc. | 1999-12-16 | 248 | 0 |
| K991761 | MAGNESIUM PRODUCT NO'S, 112-01, 112-02 | A.P. Total Care, Inc. | 1999-09-02 | 101 | 0 |
| K991762 | ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 | A.P. Total Care, Inc. | 1999-09-02 | 101 | 0 |
| K991664 | LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01 | A.P. Total Care, Inc. | 1999-08-19 | 97 | 0 |
| K991665 | HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01 | A.P. Total Care, Inc. | 1999-08-10 | 88 | 0 |
| K991867 | INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 | A.P. Total Care, Inc. | 1999-08-02 | 62 | 0 |
| K991866 | BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122 | A.P. Total Care, Inc. | 1999-08-02 | 62 | 0 |
| K991870 | ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 11 | A.P. Total Care, Inc. | 1999-07-30 | 59 | 0 |
| K991666 | TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 | A.P. Total Care, Inc. | 1999-06-30 | 47 | 0 |
| K991663 | AST/SGOT | A.P. Total Care, Inc. | 1999-06-30 | 47 | 0 |
| K991108 | CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01 | A.P. Total Care, Inc. | 1999-05-25 | 54 | 0 |
| K991244 | TOTAL IRON, MODELS FE 109-01, FE 109-02 | A.P. Total Care, Inc. | 1999-05-25 | 43 | 0 |
| K990981 | GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE | A.P. Total Care, Inc. | 1999-05-25 | 63 | 0 |
| K991111 | BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2 | A.P. Total Care, Inc. | 1999-05-25 | 54 | 0 |
| K990978 | ALBUMIN BCG, MODEL AL 103-01 | A.P. Total Care, Inc. | 1999-05-25 | 63 | 0 |
| K991109 | CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, | A.P. Total Care, Inc. | 1999-05-25 | 54 | 0 |
| K990980 | BUN, MODEL BU 104-01 | A.P. Total Care, Inc. | 1999-05-25 | 63 | 0 |
| K991247 | URIC ACID, MODEL UA112-01 | A.P. Total Care, Inc. | 1999-05-25 | 43 | 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