Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JTX — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
48 daysmedian FDA review time
189 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K901645 | ANAEROBIC ACCU-CULSHURE(TM) | Medical Laboratory Automation Systems, Inc. | 1990-07-16 | 98 | 0 |
| K897151 | ACUSON V328 AND C5432 TRANSDUCERS | Acuson Corp. | 1990-07-03 | 189 | 0 |
| K882637 | ACCU-CULSHURE TM | Accu-Med Corp. | 1988-07-06 | 9 | 0 |
| K791724 | BIO-BAG ENVIRONMENTAL CHAMBER (A & B) | Marion Laboratories, Inc. | 1979-10-17 | 48 | 0 |
| K781376 | STANDARDIZE TGCL & TGCH | American Monitor Corp. | 1978-09-14 | 36 | 0 |
| K780159 | ANASWAB | Scott Laboratories, Inc. | 1978-02-13 | 14 | 0 |
| K761241 | PRE-DUCED SURGI-SWAB & TRANSPORTER TUBE | Gibco Laboratories Life Technologies, Inc. | 1976-12-30 | 17 | 0 |
| K760063 | SPECIMEN COLLECTOR, ANAEROBIC | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-08-03 | 48 | 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