Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JIA — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
231 daysmedian FDA review time
435 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190335 | GSP Neonatal Total Galactose kit | Perkinelmer, Inc. | 2019-11-06 | 265 | 0 |
| K133652 | GSP NEONATAL TOTAL GALACTOSE KIT | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 2014-04-28 | 152 | 0 |
| K121101 | SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT | Astoria-Pacific, Inc. | 2013-06-20 | 435 | 0 |
| K071649 | NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, M | Wallac OY | 2008-08-07 | 416 | 3 |
| K990644 | QUANTASE TOTAL GALACTOSE SCREENING ASSAY | Quantase , Ltd. | 1999-06-21 | 115 | 1 |
| K990654 | QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT | Quantase , Ltd. | 1999-06-21 | 112 | 1 |
| K991498 | ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL | Neometrics, Inc. | 1999-06-16 | 48 | 0 |
| K950481 | NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT | Isolab, Inc. | 1996-02-01 | 363 | 5 |
| K951329 | IMMUCHEM GAL-MW EA | Icn Pharmaceuticals, Inc. | 1995-11-09 | 231 | 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