Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
JJO — Predicate Candidate Screening
22 FDA 510(k) clearances under this product code; the 50 most recent screened below.
47 daysmedian FDA review time
121 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K873603 | FINNIGAN MAT INCOS 50 | Finnigan Corp. | 1987-09-22 | 18 | 0 |
| K862148 | OLYMPUS AU 5000 FLAME PHOTOMETER MODULE | Olympus Corp. | 1986-09-29 | 117 | 0 |
| K843375 | ELVI 655 FLAME PHOTOMETER | Logos Scientific, Inc. | 1985-05-20 | 265 | 0 |
| K841847 | LITHIUM REAGENT | Reagent Laboratory, Inc. | 1984-08-17 | 121 | 0 |
| K834226 | FLAME PHOTOMETERS | Dr. Bruno Lange GmbH | 1984-06-22 | 199 | 0 |
| K841421 | DAILY WASH SOLUTION 5 | Reagent Laboratory, Inc. | 1984-05-11 | 36 | 0 |
| K841422 | VOLUME TEST DYE 6 | Reagent Laboratory, Inc. | 1984-05-11 | 36 | 0 |
| K840530 | SUPPLIES FOR INSTRUMENTATION LAB FLAME | Shaban Mfg. Co. | 1984-03-30 | 65 | 0 |
| K840044 | SDI PREPAX DILUKIT 29-1000 | Scientific Distributors, Inc. | 1984-03-09 | 63 | 0 |
| K833535 | POTASSIUM SODIUM ANALYSIS PRODUCTS | Shaban Mfg. Co. | 1983-12-29 | 93 | 0 |
| K832886 | FLAME PHOTOMETER T281-T282-T283 | Texas Intl. Laboratories, Inc. | 1983-12-08 | 104 | 0 |
| K832937 | SHABAN #9868 TUBING KIT-9870 STYLET | Shaban Mfg. Co. | 1983-10-14 | 45 | 0 |
| K832932 | SHABAN #9858 ASPIRATOR ASSEMBLE #9862- | Shaban Mfg. Co. | 1983-10-14 | 45 | 0 |
| K832931 | SHABAN #9852 CHIMNEY-#9854 SCREEN & | Shaban Mfg. Co. | 1983-10-14 | 45 | 0 |
| K832936 | SHABAN #9850 PUMP WINDINGS-9860 FILTER | Shaban Mfg. Co. | 1983-10-14 | 45 | 0 |
| K823480 | IL 943 FLAME PHOTOMETER | Instrumentation Laboratory CO | 1983-01-09 | 47 | 0 |
| K820631 | CORNING 480 FLAME PHOTOMETER | Corning Medical & Scientific | 1982-04-01 | 24 | 0 |
| K792087 | MICROFLAME PHOTOMETER | Gilford Instrument Laboratories, Inc. | 1979-11-13 | 27 | 0 |
| K780650 | FLAME PHOTOMETER, MODEL 455 | Corning Medical & Scientific | 1978-05-26 | 37 | 0 |
| K780649 | FLAME PHOTOMETER, MODEL 435 | Corning Medical & Scientific | 1978-05-26 | 37 | 0 |
| K771337 | I.L. MODEL 643 FLAME PHOTOMETER | Instrumentation Laboratory CO | 1977-10-18 | 91 | 0 |
| K770393 | PROPANE, HIGH PURITY, INSTRUMENT GRADE | Hycel, Inc. | 1977-04-26 | 57 | 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