Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JFS — Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
38 daysmedian FDA review time
93 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K121823 | CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLO | Wescor, Inc. | 2013-03-27 | 279 | 0 |
| K923598 | REDI-CHECK PHOTMETER Q.A. | Awareness Technology, Inc. | 1992-10-14 | 86 | 0 |
| K873127 | CHLORIDE REAGENT KIT | A-Kem, Inc. | 1987-10-23 | 74 | 0 |
| K830217 | REAGENTS CORNING CHLORIDE METER FOR | Fisher Scientific Co., LLC | 1983-02-18 | 25 | 0 |
| K823106 | RERMCO TEST CHLORIDE REAGENT | Fermco Biochemics, Inc. | 1982-11-16 | 26 | 0 |
| K820411 | LIQUIZYME CHLORIDE REAGENT | American Research Products Co. | 1982-03-08 | 24 | 0 |
| K811319 | CHLORIDE REAGENT KIT | Chem-Elec, Inc. | 1981-08-13 | 93 | 0 |
| K811701 | CHLORIDE/CARBON DIOXIDE RATE REAGENT | Chem-Elec, Inc. | 1981-07-01 | 15 | 0 |
| K810550 | SILVER ANODE | Nobel Scientific Industries, Inc. | 1981-04-08 | 37 | 0 |
| K810615 | CORNING 925 CHLORIDE METER | Corning Medical & Scientific | 1981-03-17 | 8 | 0 |
| K802080 | BAKER DIAG. ULTRARATE CHLORIDE KIT | J.T. Baker Chemical Co. | 1980-10-10 | 43 | 0 |
| K800585 | NSI CHLORIDE REAGENT KIT | Nobel Scientific Industries, Inc. | 1980-04-02 | 16 | 0 |
| K800217 | CHLORIDE REAGENT, CUP & CLEANER | Fisher Scientific Co., LLC | 1980-02-26 | 22 | 0 |
| K791690 | CHOLORDE REAGENT | Hi Chem, Inc. | 1979-09-17 | 48 | 0 |
| K790045 | REAGENT KIT, CHLORIDE/CARBON DIOXIDE | J.T. Baker Chemical Co. | 1979-02-22 | 48 | 0 |
| K781275 | CHLORIDE/CARBON DIOXIDE REAGENT SET | Nobel Scientific Industries, Inc. | 1978-08-31 | 38 | 0 |
| K781132 | CHEMLAR | Hi Chem, Inc. | 1978-08-10 | 38 | 0 |
| K771832 | CHLORIDE | Gamma Enterprises, Inc. | 1977-11-22 | 62 | 0 |
| K760394 | REAGENT, CHLORIDOMETER ACID | Bulcher Instruments | 1976-11-01 | 87 | 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