Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
JSS — Predicate Candidate Screening
49 FDA 510(k) clearances under this product code; the 50 most recent screened below.
50 daysmedian FDA review time
257 days90th percentile
49clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150031 | hemoFISH Masterpanel | Miacom Diagnostics GmbH | 2015-10-01 | 266 | 0 |
| K123418 | GRAM-NEGATIVE QUICKFISH BC | Advandx, Inc. | 2013-07-21 | 257 | 1 |
| K101558 | GNR TRAFFIC LIGHT PNA FISH | Advandx, Inc. | 2010-12-16 | 195 | 0 |
| K092236 | E.COLI/P. AERUGINOSA PNA FISH | Advandx, Inc. | 2009-12-16 | 146 | 1 |
| K092393 | EK/P. AERUGINOSA PNA FISH | Advandx, Inc. | 2009-09-01 | 27 | 1 |
| K082068 | E. COLI PNA FISH | Advandx, Inc. | 2009-06-25 | 338 | 0 |
| K081433 | EK/P. AERUGINOSA PNA FISH | Advandx, Inc. | 2009-03-26 | 309 | 0 |
| K081309 | E.COLI/P. AERUGINOSA PNA FISH | Advandx, Inc. | 2008-12-19 | 224 | 0 |
| K926002 | ALAMAR BACTERIAL IDENTIFICATION TEST PANEL | Alamar Biosciences Laboratory, Inc. | 1993-09-23 | 300 | 0 |
| K924814 | API 20E/UNISCEPT 20E | Analytical Products, Inc. | 1993-03-11 | 167 | 0 |
| K926017 | CRYSTAL RAPID STOOL/ENTERIC ID SYSTEM | Becton Dickinson Microbiology Systems | 1993-03-11 | 101 | 0 |
| K926018 | CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM | Becton Dickinson Microbiology Systems | 1993-03-11 | 101 | 2 |
| K922588 | ROCHE ENTEROTUBE II | Roche Diagnostic Systems, Inc. | 1992-09-11 | 102 | 0 |
| K912924 | RAMBACH AGAR | Rantran, Inc. | 1992-02-28 | 240 | 0 |
| K894776 | SENSITITRE INDOLE REAGENT | Radiometer America, Inc. | 1989-08-31 | 35 | 0 |
| K890626 | RAPIDEC COLI | Dms Products, Inc. | 1989-06-02 | 115 | 0 |
| K883558 | VITEK GRAM-NEGATIVE IDENTIFICATION CARD | Vitek Systems, Inc. | 1988-09-16 | 28 | 0 |
| K863603 | GI MOTILITY TEST MEDIUM W/TTC | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-09-30 | 15 | 0 |
| K861774 | QUADRA-TITER (TM) I.D. (MODIFICATION) | Microtech Medical Systems, Inc. | 1986-05-20 | 13 | 0 |
| K854733 | API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT) | Dms Products, Inc. | 1986-03-06 | 101 | 0 |
| K853009 | COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT | Roche Diagnostic Systems, Inc. | 1986-03-04 | 231 | 0 |
| K860208 | QUADRA-TITER I.D. | Microtech Medical Systems, Inc. | 1986-03-03 | 40 | 0 |
| K852871 | IDS RAPID SS/U SYSTEM | Innovative Diagnostic Systems, Inc. | 1985-07-23 | 15 | 0 |
| K852110 | IDS RAPID E PLUS SYSTEM | Innovative Diagnostic Systems, Inc. | 1985-06-04 | 20 | 0 |
| K851978 | LYFO-KWIK OMI KIT | Micro-Bio-Logics | 1985-06-04 | 28 | 0 |
| K843571 | RIM-UREA | Austin Biological Laboratories | 1984-10-01 | 20 | 0 |
| K834090 | TITERTEK ENTEROBAC* | Flow Laboratories, Inc. | 1984-01-13 | 46 | 0 |
| K833612 | FLUOR-B. FRAG. DIRECT FLUORESCENT ANTI | Petra Biomedical Products, Inc. | 1983-12-12 | 60 | 0 |
| K833613 | FLUOR-B MEL A DIRECT FLUORESCENT ANTI | Petra Biomedical Products, Inc. | 1983-12-12 | 60 | 0 |
| K831672 | SPECTRUM-10 | Austin Biological Laboratories | 1983-06-22 | 30 | 0 |
| K830698 | QUANTUM II BACTERIAL IDENT. SYSTEM | Abbott Laboratories | 1983-04-08 | 32 | 0 |
| K830396 | UREA-PDA DISK | Remel Co. | 1983-03-08 | 29 | 0 |
| K813609 | RAPID E | Dms Laboratories | 1982-02-04 | 37 | 0 |
| K813164 | SYSTEK #1 EIKEN | Syn-Kit, Inc. | 1981-12-31 | 51 | 0 |
| K812286 | MINITECK ENTERIC BROTH & ENTEROBACTER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-10-02 | 50 | 0 |
| K811765 | SENSITITIRE AP60 | Gibco Laboratories Life Technologies, Inc. | 1981-08-13 | 52 | 0 |
| K811434 | SCEPTOR ID GRAM NEGATIVE MIC/ID PANELS | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-06-26 | 35 | 0 |
| K792058 | ENTERIC-TEK | Flow Laboratories, Inc. | 1980-01-11 | 88 | 0 |
| K791789 | 3M MICROBIAL PROFILE SYSTEM GRAM | 3M Company | 1979-11-16 | 63 | 0 |
| K791932 | AMS ENTEROBACTERIACEASE CARE | Vitek Systems, Inc. | 1979-11-13 | 47 | 0 |
| K791991 | STREP-SPEC | Micro-Media Systems, Inc. | 1979-11-13 | 41 | 0 |
| K782056 | CORD, ENTEROBACTERIACEAE BIOCHEMICAL | Vitek Systems, Inc. | 1979-01-26 | 46 | 0 |
| K781816 | INOCULATOR, AIM-4 MICROPROCESSOR | Axford Manufacturing , Ltd. | 1978-12-07 | 41 | 0 |
| K781368 | MICRODILUTION GRAM-NEGATIVE ID. PANEL | Cnr Labs | 1978-10-03 | 56 | 0 |
| K781367 | MICRODILUTION STREP ID. PANEL | Cnr Labs | 1978-10-03 | 56 | 0 |
| K781427 | MS-2 BACTERIAL ID. SYSTEM | Abbott Laboratories | 1978-09-27 | 36 | 0 |
| K781236 | ENTEROTUBE II | Hoffmann-La Roche, Inc. | 1978-08-31 | 42 | 0 |
| K771703 | ENTERIC 20 | Inolex Corp./Div of Biomedical | 1977-10-04 | 25 | 0 |
| K760790 | MICRO-ID | General Diagnostics | 1976-10-29 | 22 | 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