Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JWX — Predicate Candidate Screening
20 FDA 510(k) clearances under this product code; the 50 most recent screened below.
37 daysmedian FDA review time
245 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090964 | BINAXNOX STAPHYLOCOCCUS AUREUS TEST | Binax, Inc. | 2009-12-16 | 254 | 0 |
| K972030 | STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS | Oxoid , Ltd. | 1997-09-08 | 98 | 1 |
| K964315 | REMEL STAPH LATEX KIT | Remel, L.P. | 1997-02-07 | 101 | 0 |
| K945538 | STAPHAUREX PLUS(TM) | Murex Diagnostics Limitd | 1995-06-01 | 199 | 0 |
| K926173 | STAPH-A-LEX(TM) SYSTEM | Trinity Laboratories, Inc. | 1993-08-10 | 245 | 0 |
| K923212 | SLIDEX STAPH-KIT | Biomerieux Vitek, Inc. | 1992-09-28 | 89 | 1 |
| K905617 | VISI-STAPH | Connecticut Diagnostics, Ltd. | 1991-03-29 | 105 | 0 |
| K902259 | AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT | Orthomet, Inc. | 1990-06-18 | 28 | 0 |
| K874019 | STAPHSLIDE | Ncs Diagnostics, Inc. | 1987-10-28 | 26 | 0 |
| K854278 | NEG COMBO BREAKPOINT PANEL POS COMBO | American Micro Scan | 1986-03-04 | 131 | 0 |
| K855220 | V-TREND KIT STAPH LATEX TEST | Texas Immunology, Inc. | 1986-03-03 | 63 | 0 |
| K852997 | RAPI - STAPH | Advanced Medical Technology, Inc. | 1985-08-19 | 35 | 0 |
| K843560 | BACTO STAPHYLOCOCCUS LATEX TEST | Difco Laboratories, Inc. | 1984-10-01 | 21 | 0 |
| K831918 | LA-STAPH IDENTIFICATION SYSTEM | Immuno-Mycologics, Inc. | 1983-06-08 | 0 | 0 |
| K830783 | VERI-STAPH | Zeus Technologies | 1983-04-08 | 28 | 0 |
| K822558 | LSM AGAR | Granite Diagnostics, Inc. | 1982-09-14 | 21 | 0 |
| K822144 | IDS STAPHYLOCHROME TEST | Innovative Diagnostic Systems, Inc. | 1982-08-24 | 34 | 0 |
| K821962 | BBL STAPHYSLIDE TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-07-30 | 29 | 0 |
| K813614 | STAPH TRAC | Dms Laboratories | 1982-02-04 | 37 | 0 |
| K811098 | SERO-STAT STAPHYLOCOCCUS TEST | Scott Laboratories, Inc. | 1981-05-05 | 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