Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
JSK — Predicate Candidate Screening
70 FDA 510(k) clearances under this product code; the 50 most recent screened below.
35 daysmedian FDA review time
57 days90th percentile
70clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K881949 | ATS NAC-PAC SET | Alpha-Tec Systems, Inc. | 1988-05-25 | 15 | 0 |
| K881879 | ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 | Alpha-Tec Systems, Inc. | 1988-05-13 | 9 | 0 |
| K881566 | HEMOGLOBIN POWDER | Acumedia Manufacturers, Inc. | 1988-04-18 | 7 | 0 |
| K861997 | PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE | Hazleton Research Products, Inc. | 1986-06-10 | 18 | 0 |
| K861824 | GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) | Flow Laboratories, Inc. | 1986-05-20 | 8 | 0 |
| K861823 | GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN) | Flow Laboratories, Inc. | 1986-05-20 | 8 | 0 |
| K861791 | PENICILLIN-STREPTOMYCIN-FUNGIZONE | Flow Laboratories, Inc. | 1986-05-20 | 11 | 0 |
| K855172 | KWI (TM) G-CO/TWO | Micro-Bio-Logics | 1986-02-20 | 56 | 0 |
| K853546 | ABBOTT CATION SUPPLEMENT SOLUTION | Abbott Laboratories | 1985-09-06 | 11 | 0 |
| K850302 | SUPLEX & SUPLEX DILUENT | Pro-Lab, Inc. | 1985-03-22 | 59 | 0 |
| K850299 | C.N.V.T. | Pro-Lab, Inc. | 1985-03-20 | 57 | 0 |
| K850307 | CAMPYLOBACTER SUPPLEMENT-BLASER/WANG | Pro-Lab, Inc. | 1985-03-20 | 57 | 0 |
| K850300 | MUCOLYSE | Pro-Lab, Inc. | 1985-03-20 | 57 | 0 |
| K850308 | C.L.A.T. | Pro-Lab, Inc. | 1985-03-20 | 57 | 0 |
| K850306 | CAMPYLOBACTER SUPPLEMENT -SKIRROW | Pro-Lab, Inc. | 1985-03-20 | 57 | 0 |
| K850301 | YEAST DIALYSATE | Pro-Lab, Inc. | 1985-03-20 | 57 | 0 |
| K850738 | SUPPLEMENT FOR CULTURE MEDIUM | Roseville Medical Laboratoriesu | 1985-03-20 | 28 | 0 |
| K840330 | PRESTON CAMPYLOBACTER SELECTIVE SUPP | Oxoid U.S.A., Inc. | 1984-05-11 | 107 | 0 |
| K840333 | LEGIONELLA BMPA SELECTIVE SUPPLE | Oxoid U.S.A., Inc. | 1984-05-11 | 107 | 0 |
| K840331 | LEGIONELLA MWY SELECTIVE SUPPLEMENT | Oxoid U.S.A., Inc. | 1984-05-11 | 107 | 0 |
| K834115 | CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT | Bartels Immunodiagnostic Supplies, Inc. | 1984-03-23 | 115 | 0 |
| K834066 | TINSDALE ENRICHMENT | Remel Co. | 1984-01-04 | 40 | 0 |
| K833210 | LACTOSE | Acumedia Manufacturers, Inc. | 1983-10-27 | 38 | 0 |
| K833019 | CAMPYLOBACTER SELECTIVE SUPPLE-BLASER | Gibco Laboratories Life Technologies, Inc. | 1983-10-14 | 38 | 0 |
| K833018 | CAMPYLOBACTER-SELECTIVE SUPPLE-SKIRROW | Gibco Laboratories Life Technologies, Inc. | 1983-10-14 | 38 | 0 |
| K833020 | CAMPYLOBACTER SELECTIVE SUPPLE-BUTZLER | Gibco Laboratories Life Technologies, Inc. | 1983-10-14 | 38 | 0 |
| K832902 | MIDDLEBROOK ADC ENRICHMENT | Gibco Laboratories Life Technologies, Inc. | 1983-09-26 | 28 | 0 |
| K831469 | LEGIONELLA CYE AGAR BASE & BCYE SUPPL | Oxoid U.S.A., Inc. | 1983-06-08 | 33 | 4 |
| K831219 | CLOSTRIDIUM DIFFICILE SELECTIVE SUPPLE | Gibco Laboratories Life Technologies, Inc. | 1983-05-13 | 28 | 0 |
| K820610 | GELRITE | Kelco | 1982-10-27 | 233 | 0 |
| K822458 | YEAST AUTOLYXATE SUPPLEMENT | Oxoid U.S.A., Inc. | 1982-09-14 | 29 | 0 |
| K822460 | LCAT ANTIBIOTIC SUPPLEMENT | Oxoid U.S.A., Inc. | 1982-09-14 | 29 | 0 |
| K822459 | VCAT ANTIBIOTIC SUPPLEMENT | Oxoid U.S.A., Inc. | 1982-09-14 | 29 | 0 |
| K822511 | YERSINIA SELECTIVE SUPPLEMENT | Gibco Laboratories Life Technologies, Inc. | 1982-09-14 | 25 | 0 |
| K822461 | N-S ANAEROBE SUPPLEMENT | Oxoid U.S.A., Inc. | 1982-09-14 | 29 | 0 |
| K822462 | G-N ANAEROBE SUPPLEMENT | Oxoid U.S.A., Inc. | 1982-09-14 | 29 | 0 |
| K811732 | THIOTONE PEPTONE | Acumedia Manufacturers, Inc. | 1981-07-02 | 14 | 0 |
| K811649 | GELYSATE | Acumedia Manufacturers, Inc. | 1981-07-02 | 22 | 0 |
| K811730 | BIOSATE | Acumedia Manufacturers, Inc. | 1981-07-02 | 14 | 0 |
| K811652 | POLYPEPTONE PEPTONE | Acumedia Manufacturers, Inc. | 1981-07-02 | 22 | 0 |
| K811653 | PHYTONE | Acumedia Manufacturers, Inc. | 1981-07-02 | 22 | 0 |
| K811518 | VCNT ANTIBIOTIC SUPPLEMENT | Oxoid U.S.A., Inc. | 1981-06-24 | 27 | 0 |
| K811517 | VCN SUPPLEMENT | Oxoid U.S.A., Inc. | 1981-06-24 | 27 | 0 |
| K811516 | LEGIONELLA, GROWTH & SELECTIVE, SUPP. | Oxoid U.S.A., Inc. | 1981-06-24 | 27 | 0 |
| K811225 | HUMAN BLOOD IN ALSEVER'S | Dutchland Laboratories, Inc. | 1981-06-12 | 39 | 0 |
| K811360 | YEAST EXTRACT | Acumedia Manufacturers, Inc. | 1981-05-29 | 15 | 0 |
| K811357 | HEMOGLOBIN POWDER | Acumedia Manufacturers, Inc. | 1981-05-29 | 15 | 0 |
| K811361 | PANCREATIC HYDROLYSATE OF HEART MUSCLE | Acumedia Manufacturers, Inc. | 1981-05-29 | 15 | 0 |
| K810932 | VITOX | Oxoid U.S.A., Inc. | 1981-04-14 | 8 | 0 |
| K810591 | PACT SUPPLEMENT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-03-20 | 15 | 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