Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JJJ — Predicate Candidate Screening
63 FDA 510(k) clearances under this product code; the 50 most recent screened below.
42 daysmedian FDA review time
125 days90th percentile
63clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962762 | SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR | Biotraces, Inc. | 1996-08-16 | 31 | 0 |
| K946387 | CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER | Capintec, Inc. | 1995-03-30 | 125 | 0 |
| K920559 | ABBOTT VERTEX ANALYZER | Abbott Laboratories | 1992-03-19 | 41 | 0 |
| K900087 | GENESYS 6000 GAMMA COUNTER | Laboratory Technologies, Inc. | 1990-07-19 | 195 | 0 |
| K896202 | MATRIX(TM)-96 | Canberra Industries, Inc. | 1990-01-02 | 68 | 0 |
| K894902 | SOURCERER | Oakfield Instruments, Ltd. | 1989-10-17 | 77 | 0 |
| K884091 | SOURCERER | John Caunt Scientific , Ltd. | 1989-02-02 | 127 | 0 |
| K884269 | SAMPLE IDENTIFICATION STATION MODEL 38010 | Icn Micromedic Systems | 1989-01-09 | 90 | 0 |
| K874094 | 1205 BETAPLATE LIQUID SCINTILLATION COUNTER | Lkb Instruments, Inc. | 1987-11-04 | 35 | 0 |
| K872430 | ISO-DATA 500 SERIES GAMMA COUNTER | Iso-Data, Inc. | 1987-08-21 | 60 | 0 |
| K872429 | ISO-DATA 100 SERIES GAMMA COUNTER | Iso-Data, Inc. | 1987-08-21 | 60 | 0 |
| K870115 | BERTHOLD LB 2103,2104-XT/PC/AT,951G GAMMA COUNTERS | Berthold Analytical Instruments, Inc. | 1987-03-31 | 78 | 0 |
| K862206 | TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER | Micromedic Systems | 1986-08-04 | 55 | 0 |
| K851164 | DENTOCULT CULTURE-PADDLE | Orion Corp. | 1985-10-29 | 221 | 0 |
| K851689 | GENESYS GAMMA COUNTER | Laboratory Technologies, Inc. | 1985-08-07 | 103 | 0 |
| K852434 | 1208 BETACORD AND 1208 BETCORD M | Lkb Instruments, Inc. | 1985-08-02 | 53 | 0 |
| K842902 | MICROSTAT GAMMA COUNTER | Micromedic Systems | 1984-08-09 | 17 | 0 |
| K841352 | ND1200 RIA COUNTER | Nuclear Data, Inc. | 1984-05-02 | 30 | 0 |
| K834508 | CORNING 4000 MULTI-WELL GAMMA COUNTER | Corning Medical & Scientific | 1984-03-16 | 86 | 0 |
| K832734 | KEMTEK 400 RIA GAMMA COUNTER | Kemble Instruments, Inc. | 1983-10-14 | 71 | 0 |
| K832736 | KEMTEK 104 RIA GAMMA COUNTER | Kemble Instruments, Inc. | 1983-09-29 | 52 | 0 |
| K832735 | KEMTEK 103 RIA GAMMA COUNTER | Kemble Instruments, Inc. | 1983-09-29 | 56 | 0 |
| K832210 | GAMMA PHOTON GAMMA COUNTER | Medical & Scientific Designs, Inc. | 1983-08-24 | 48 | 0 |
| K832209 | KINETI COUNT 24 GAMMA COUNTER | Medical & Scientific Designs, Inc. | 1983-08-24 | 48 | 0 |
| K832002 | NML-5010/5020 MULTI-DETECTOR SYSTEM | Nuclear Medical Laboratories, Inc. | 1983-08-08 | 47 | 0 |
| K830751 | KEMTEK 102 | Kemble Instruments, Inc. | 1983-04-06 | 27 | 0 |
| K830365 | KINETI COUNT 48 IMMUNOASSAY SYSTEM | Medical & Scientific Designs, Inc. | 1983-03-10 | 34 | 0 |
| K823240 | CAP-RIA 16 | Capintec, Inc. | 1982-12-03 | 32 | 0 |
| K822293 | IMMU-COUNT 404 | Kemble Instruments, Inc. | 1982-08-24 | 22 | 0 |
| K821892 | PHILLIPS RADIATION MEASURING INSTRUMENT | Long Island Scientific | 1982-07-13 | 15 | 0 |
| K821494 | RIA STAT 16 | E. R. Squibb & Sons, Inc. | 1982-06-03 | 16 | 0 |
| K820376 | MICROMEDIC SYSTEMS ISOFLEX | Micromedic Systems | 1982-03-16 | 35 | 0 |
| K820137 | IMMU-COUNT | Kemble Instruments, Inc. | 1982-02-05 | 18 | 0 |
| K813472 | LS 5800 SERIES LIQUID SCINTILLATION | Beckman Instruments, Inc. | 1981-12-29 | 15 | 0 |
| K810345 | LIQUID SCINTILLATION SPECTROPHOTOMETER | Beckman Instruments, Inc. | 1981-02-25 | 15 | 0 |
| K802578 | PACE-4-AUTOMATIC RIA GAMMA-COUTER | Philips Medical Systems (Cleveland), Inc. | 1980-12-18 | 59 | 0 |
| K801264 | NUCLEAR ENTERPRISES 1600/GAMMA COUNTER | Nuclear Ent. , Ltd. | 1980-06-26 | 29 | 0 |
| K801263 | NUCLEAR ENTERPRISES 1612 MULTI-WELL | Nuclear Ent. , Ltd. | 1980-06-20 | 23 | 0 |
| K801245 | ATOMLIGHT (LIQUID SCINTILLATION SOLUTION | New England Nuclear | 1980-06-20 | 24 | 0 |
| K800601 | HYDRAGAMMA 16 | Innotron of Oregon, Inc. | 1980-04-10 | 24 | 0 |
| K800388 | NML 5000 AUTO. GAMMA SCINT. COUNTER | Nuclear Medical Laboratories, Inc. | 1980-03-12 | 16 | 0 |
| K790961 | LIQUID SCINTILLATION COUNTER | Nuclear Ent. , Ltd. | 1979-06-28 | 37 | 0 |
| K790905 | NUCLEAR SAMPLE READER | Abbott Laboratories | 1979-06-15 | 35 | 0 |
| K780790 | IDI 200 GAMMA COUNTER | Iso-Data, Inc. | 1978-06-22 | 38 | 0 |
| K780341 | SCINTILLATION, LIQUID, RACKBETA | Lkb Instruments, Inc. | 1978-05-26 | 86 | 0 |
| K771614 | AUTO. WELL TYPE GAMMA COUNTERS | Actus, Inc. | 1978-04-12 | 232 | 0 |
| K780344 | GAMMA COUNTER | Lkb Instruments, Inc. | 1978-04-12 | 42 | 0 |
| K771612 | WELL TYPE GAMMA COUNTER | Actus, Inc. | 1978-04-10 | 230 | 0 |
| K771613 | WELL TYPE GAMMA COUNTER | Actus, Inc. | 1978-04-10 | 230 | 0 |
| K780383 | COUNTER, RADIOASSAY, AUTO., MICROMEDIC | Micromedic Systems | 1978-03-22 | 13 | 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