Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JGP — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
69 daysmedian FDA review time
259 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K070757 | MICROPROTEIN REAGENT SET | Pointe Scientific, Inc., | 2007-12-04 | 259 | 0 |
| K964960 | VITROS CHEMISTRY PRODUCTS UPRO SLIDES | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-02-18 | 69 | 0 |
| K863112 | PROTEINMETER | J. D. Assoc. | 1986-12-10 | 119 | 0 |
| K821534 | HEMATOLOGY DATA MANAGEMENT SYS | Biovation, Inc. | 1982-06-10 | 17 | 0 |
| K792347 | MICRO LOWRY PROTEINTEST | Panmed, Inc. | 1979-12-06 | 17 | 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