Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
J. D. Assoc. — Predicate Candidate Screening
34 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
44 daysmedian FDA review time
122 days90th percentile
34clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K863054 | AST S.C.E. (GOT) | J. D. Assoc. | 1987-01-13 | 154 | 0 |
| K863103 | PEG 6,000 | J. D. Assoc. | 1987-01-13 | 153 | 0 |
| K863069 | MAGNESIOMETER | J. D. Assoc. | 1986-12-31 | 141 | 0 |
| K863079 | CREATINKINETIC | J. D. Assoc. | 1986-12-12 | 122 | 0 |
| K863068 | LDH S.C.E. | J. D. Assoc. | 1986-12-10 | 120 | 0 |
| K863053 | ALT S.C.E. (GPT) | J. D. Assoc. | 1986-12-10 | 120 | 0 |
| K863112 | PROTEINMETER | J. D. Assoc. | 1986-12-10 | 119 | 0 |
| K863066 | TRANSFERMETER | J. D. Assoc. | 1986-12-04 | 114 | 0 |
| K863102 | GLUCOMETER-E | J. D. Assoc. | 1986-11-24 | 103 | 0 |
| K863109 | FERROFAST | J. D. Assoc. | 1986-11-24 | 103 | 0 |
| K863056 | BILIRUBIN TOTAL | J. D. Assoc. | 1986-11-24 | 104 | 0 |
| K863114 | PIASTRINIT | J. D. Assoc. | 1986-11-06 | 85 | 0 |
| K863059 | CALCIOMETER | J. D. Assoc. | 1986-09-26 | 45 | 0 |
| K863057 | BILIRUBIN TOTAL DIRECT | J. D. Assoc. | 1986-09-26 | 45 | 0 |
| K863075 | TRIGLYCERIDES-E | J. D. Assoc. | 1986-09-26 | 45 | 0 |
| K863065 | HDL CHOLESTEROL-E | J. D. Assoc. | 1986-09-25 | 44 | 0 |
| K863062 | CHOLESTEROL-E (TOTAL) | J. D. Assoc. | 1986-09-25 | 44 | 0 |
| K863050 | ALBUMETER | J. D. Assoc. | 1986-09-11 | 30 | 0 |
| K863070 | FAST MUCOPROTEINS | J. D. Assoc. | 1986-09-11 | 30 | 0 |
| K863111 | CHOLINESTERASE | J. D. Assoc. | 1986-09-11 | 29 | 0 |
| K863064 | CHOLESTEROL-E (FREE) | J. D. Assoc. | 1986-09-11 | 30 | 0 |
| K863063 | CHOLESTEROL-E FAST (TOTAL) | J. D. Assoc. | 1986-09-09 | 28 | 0 |
| K863078 | CREATININE-E | J. D. Assoc. | 1986-09-09 | 28 | 0 |
| K863051 | ALP S.C.E. | J. D. Assoc. | 1986-09-09 | 28 | 0 |
| K863073 | TOTAL LIPIDS | J. D. Assoc. | 1986-09-09 | 28 | 0 |
| K863076 | UREAFAST | J. D. Assoc. | 1986-09-09 | 28 | 0 |
| K863071 | PHOSPHOLIPIDS-E | J. D. Assoc. | 1986-09-09 | 28 | 0 |
| K863074 | TOTAL PROTEINS | J. D. Assoc. | 1986-09-09 | 28 | 0 |
| K863052 | ALPHA AMYLASE | J. D. Assoc. | 1986-09-09 | 28 | 0 |
| K863055 | BILIFAST | J. D. Assoc. | 1986-09-09 | 28 | 0 |
| K863072 | FOSFOROMETER | J. D. Assoc. | 1986-09-09 | 28 | 0 |
| K863113 | URICMETER | J. D. Assoc. | 1986-09-09 | 27 | 0 |
| K863061 | CLOROFAST | J. D. Assoc. | 1986-09-09 | 28 | 0 |
| K863104 | TOTAL HEMOGLOBIN | J. D. Assoc. | 1986-09-04 | 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