Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JIH · Predicate Candidate Screening
12 FDA 510(k) clearances under this product code; the 50 most recent screened below.
107 daysmedian FDA review time
213 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050338 | MODIFICATION TO: INSTAREAD LITHIUM SYSTEM | Akers Biosciences, Inc. | 2005-03-04 | 21 | 0 |
| K031579 | INSTAREAD LITHIUM SYSTEM | Akers Laboratories, Inc. | 2003-12-19 | 213 | 0 |
| K011033 | DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 | Dade Behring, Inc. | 2001-06-07 | 63 | 0 |
| K934106 | KODAK EKTACHEM DTSC II SLIDES (LI) | Eastman Kodak Company | 1994-04-25 | 245 | 0 |
| K924488 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI) | Eastman Kodak Company | 1993-01-26 | 145 | 1 |
| K921403 | MODEL 654 ANALYZER | Ciba Corning Diagnostics Corp. | 1992-07-30 | 128 | 0 |
| K895465 | AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE | Baxter Healthcare Corp | 1989-12-27 | 107 | 0 |
| K894328 | TDX(R) LITES(TM) LITHIUM | Abbott Laboratories | 1989-11-13 | 122 | 0 |
| K830636 | POTASSIUM DILUENT | Shaban Mfg. Co. | 1983-04-05 | 35 | 0 |
| K800039 | LITHIUM DILUENT (1500 MM/E) | Gilford Diagnostics | 1980-01-21 | 14 | 0 |
| K771303 | FLAME PHOTOMETER MODEL 460 | Corning Medical & Scientific | 1977-08-22 | 38 | 0 |
| K770824 | FLAME PHOTOMETER MOLEL 4600, KDA | American Monitor Corp. | 1977-07-15 | 72 | 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