Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JTC — Predicate Candidate Screening
66 FDA 510(k) clearances under this product code; the 50 most recent screened below.
29 daysmedian FDA review time
70 days90th percentile
66clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K924907 | FILTERMATE UNIVERSAL HARVESTER | Packard Instrument Co., Inc. | 1992-12-01 | 63 | 0 |
| K901808 | MICROMATE 196 MODEL A961960 | Packard Instrument Co., Inc. | 1990-06-20 | 61 | 0 |
| K894645 | IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM | Dynatech Laboratories, Inc. | 1989-10-17 | 85 | 0 |
| K892369 | MULTI-PROBE HEAD PLUS | Hamilton Co. | 1989-06-02 | 57 | 0 |
| K891768 | GENETIC SYSTEMS MICROPLATE WASHER | Genetic Systems Corp. | 1989-05-01 | 38 | 0 |
| K891766 | GENETIC SYSTEMS MICROPLATE STRIP WASHER | Genetic Systems Corp. | 1989-05-01 | 38 | 0 |
| K891765 | GENETIC SYSTEMS PIPETTOR/DILUTOR | Genetic Systems Corp. | 1989-05-01 | 38 | 0 |
| K884695 | WASHER 500 MICROELISA SYSTEM | Organon Teknika Corp. | 1988-12-13 | 34 | 0 |
| K884125 | BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403 | Bio-Tek Instruments, Inc. | 1988-12-02 | 63 | 1 |
| K874598 | DYNATECH MR 250 MANUAL MICROELISA READER | Dynatech Laboratories, Inc. | 1987-11-20 | 11 | 0 |
| K873542 | MICROPLATE AUTO-WASHER (MOTORIZED STAGE) | Genetic Systems Corp. | 1987-09-23 | 22 | 0 |
| K871945 | MICROLAB AT | Hamilton Co. | 1987-05-29 | 10 | 1 |
| K863423 | CODE-A-WELL SERIES 1-1000 AND SERIES 1-1100 | Plastic Injectors, Inc. | 1986-09-16 | 12 | 0 |
| K863374 | CODE-A-WELL SERIES 1-600, 1-625 | Plastic Injectors, Inc. | 1986-09-11 | 8 | 0 |
| K862802 | MULTI-CHANNEL MICROPIPETTES | Dynatech Laboratories, Inc. | 1986-08-01 | 10 | 0 |
| K862066 | TITERTEK MICROPLATE WASHER S-12 | Flow Laboratories, Inc. | 1986-06-05 | 6 | 0 |
| K860617 | POLYPET | Instrumed, Inc. | 1986-03-03 | 12 | 0 |
| K853920 | BIO-TEK EL 401 HANDHELD MICROPLATE WASHER | Bio-Tek Instruments, Inc. | 1985-10-22 | 29 | 0 |
| K853380 | SPR 2 AUTODILUTER | Scientific Sales Intl., Inc. | 1985-09-12 | 31 | 0 |
| K851019 | MIC-CONCEPT INOCULUM SEED TRAY | Microtech Medical Systems, Inc. | 1985-03-29 | 17 | 0 |
| K851020 | MIC-CONCEPT INOCULATOR | Microtech Medical Systems, Inc. | 1985-03-29 | 17 | 0 |
| K850908 | TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA | Flow Laboratories, Inc. | 1985-03-25 | 20 | 0 |
| K850249 | BIO-TEK AUTOMATED MICROPLATE WASHER EL402 | Bio-Tek Instruments, Inc. | 1985-03-13 | 50 | 0 |
| K850371 | INTIWASH MANUAL MICROPLATE WASHER | Inti Corp. | 1985-03-11 | 39 | 0 |
| K844891 | SLT 225 WASHER/DISPENSER FOR MICRO TITERPLATES | Slt Labinstruments, Inc. | 1985-02-25 | 70 | 0 |
| K844893 | SLT 223 DISPENSER FOR MICROTITERPLATES | Slt Labinstruments, Inc. | 1985-02-25 | 70 | 0 |
| K844568 | TITERTEK DULUTER/DISPENSER 78-640-00 | Flow Laboratories, Inc. | 1985-01-30 | 68 | 0 |
| K844552 | BIO-STAT III PLATE WASHER | Whittaker Bioproducts, Inc. | 1985-01-30 | 70 | 0 |
| K844500 | TITERTEK MICROPLATE WASHER 120 | Flow Laboratories, Inc. | 1985-01-22 | 63 | 0 |
| K843272 | T.I.M.E. DISPENSER | Dynatech Laboratories, Inc. | 1984-09-14 | 25 | 0 |
| K842848 | CODE-A-WELL 350 MICROTITRATION STRIPS | Plastic Injectors, Inc. | 1984-09-07 | 49 | 0 |
| K831462 | API UNISCEPT PLUS 140 INOCULATOR | Analytical Products, Inc. | 1983-08-12 | 98 | 0 |
| K832203 | MULTI-TITER DISPENSER | Hamilton Co. | 1983-08-08 | 32 | 0 |
| K831640 | WASHER 6000 MICRO-C LISA SYSTEM | Organon Teknika Corp. | 1983-08-08 | 77 | 0 |
| K831644 | PIPETTE 12 CHANNEL | Organon Teknika Corp. | 1983-08-01 | 70 | 0 |
| K831341 | API UNISCEPT PLUS AUTOINOCULATOR | Analytical Products, Inc. | 1983-06-02 | 38 | 0 |
| K830059 | MUELLER HINTON W/50% SHEEP BLOOD | bioMerieux, Inc. | 1983-02-09 | 29 | 0 |
| K823137 | OCTAPETTES | Corning Costar Corp. | 1982-12-03 | 39 | 0 |
| K823218 | DISPOSABLE DISPENSE MANIFOLD | Dynatech Laboratories, Inc. | 1982-11-16 | 19 | 0 |
| K821961 | 96 WELL DISPENSER | Skatron, Inc. | 1982-07-22 | 21 | 0 |
| K820992 | MICROPLATE WASHING DEVICE | Skatron, Inc. | 1982-05-03 | 25 | 0 |
| K820821 | MIC-2000 PLUS, 96 CHANNEL DISPENSER | Dynatech Corp. | 1982-04-14 | 21 | 0 |
| K812860 | IMMUNOASSAY PLATE | Skatron, Inc. | 1981-10-26 | 13 | 0 |
| K812818 | TITERTEK AUTODROP | Flow Laboratories, Inc. | 1981-10-23 | 16 | 0 |
| K810719 | REPLICA PLATER | Dynatech Corp. | 1981-04-01 | 15 | 0 |
| K810659 | AUTODILUTER III | Dynatech Corp. | 1981-03-31 | 20 | 0 |
| K810229 | SCEPTOR SYSTEM AUTOMATED MODEL 216 | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-02-09 | 13 | 0 |
| K803244 | ASSAY STRIPS | Corning Costar Corp. | 1981-02-02 | 41 | 0 |
| K803243 | SEROCLUSTER FLEXIBLE VINYL U & V PL. | Corning Costar Corp. | 1981-01-28 | 36 | 0 |
| K803242 | SEROCLUSTER EIA PLATES | Corning Costar Corp. | 1981-01-28 | 36 | 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