Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JGT — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
74 daysmedian FDA review time
81 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K896829 | TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD) | Technicon Instruments Corp. | 1990-02-23 | 81 | 0 |
| K891574 | LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030 | Em Diagnostic Systems, Inc. | 1989-06-09 | 81 | 0 |
| K841610 | COMPONENTS FOR POTASSIUM, SODIUM CHLO | Shaban Mfg. Co. | 1984-05-25 | 46 | 0 |
| K840216 | SODIUM/POTASSIUM REAGENT SYS | Sclavo, Inc. | 1984-03-19 | 60 | 0 |
| K834248 | PARALLEL FLAME PHOTOMETER & SODIUM | American Monitor Corp. | 1984-01-30 | 54 | 0 |
| K811886 | CESIUM DILUENT 7.5M | Gilford Diagnostics | 1981-07-23 | 22 | 0 |
| K801892 | KLINAR REAGENT PAK, #36010 | Hi Chem, Inc. | 1980-10-23 | 76 | 0 |
| K770774 | LYTETEK SYSTEM | Boehringer Mannheim Corp. | 1977-07-11 | 74 | 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