Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JTT — Predicate Candidate Screening
14 FDA 510(k) clearances under this product code; the 50 most recent screened below.
76 daysmedian FDA review time
94 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983310 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACI | Accumed Intl., Inc. | 1998-12-17 | 87 | 0 |
| K935805 | PASCO MIC AND MIC/ID PANELS | Pasco Laboratories, Inc. | 1994-06-13 | 193 | 0 |
| K895362 | BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-12-01 | 94 | 0 |
| K880574 | MODIFIED IMIPENEM SUSCEPTIBILITY POWDER | Merck, Sharp & Dohme | 1988-05-04 | 84 | 0 |
| K872081 | CIPRO (TM) DIAGNOSTIC POWDER | Miles Pharmaceuticals | 1987-06-15 | 17 | 0 |
| K864442 | NORFLOXACIN SUSCEPTIBILITY POWDER | Merck, Sharp & Dohme | 1986-12-11 | 29 | 0 |
| K860031 | GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK | Organon Teknika Corp. | 1986-03-06 | 59 | 0 |
| K855071 | IMIPENEM SUSCEPTIBILITY POWDER | Merck, Sharp & Dohme | 1986-03-06 | 77 | 0 |
| K855106 | IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645 | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-03-06 | 73 | 1 |
| K855207 | IMIPENEM 10 MCG SENSITIVITY DISCS | Difco Laboratories, Inc. | 1986-03-06 | 66 | 0 |
| K830758 | AZLIN AZLOCILIN SODIUM-DIAG. REAGENT | Miles Laboratories, Inc. | 1983-05-25 | 76 | 0 |
| K822866 | MOXALACTAM | Lilly Research Laboratories | 1982-12-28 | 92 | 0 |
| K822329 | ANTITUBERCULOUS DRUGS (SIRE) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-09-02 | 30 | 0 |
| K820578 | MEZLIN DIAGNOSTIC REAGENT | Miles Pharmaceuticals | 1982-05-12 | 70 | 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