Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

LQF — Predicate Candidate Screening

15 FDA 510(k) clearances under this product code; the 50 most recent screened below.

124 daysmedian FDA review time
244 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K921435ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTUREGen-Probe, Inc.1992-07-231201
K904463ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TESTGen-Probe, Inc.1990-11-13430
K897077ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTUREGen-Probe, Inc.1990-08-232440
K896494ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TESTGen-Probe, Inc.1990-08-232830
K897078ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTUREGen-Probe, Inc.1990-05-021310
K896492ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TESTGen-Probe, Inc.1990-04-161540
K896493ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TESTGen-Probe, Inc.1990-04-111491
K900202SNAP MYCOBACTERIA AVIUM COMPLEXSyngene, Inc.1990-04-03770
K900292SNAP M. TUBERCULOSIS COMPLEXSyngene, Inc.1990-04-03710
K890089RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAEGen-Probe, Inc.1989-03-13620
K871795RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER.Gen-Probe, Inc.1987-07-30840
K864597GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIAGen-Probe, Inc.1987-04-201470
K862613RAPID IDENT. TEST FOR MYCOBACTERIUM AVIUM COMPLEXGen-Probe, Inc.1986-11-101240
K862614RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEXGen-Probe, Inc.1986-11-101240
K860782GEN-PROBE MYCOBACTERIUM RAPID CONFIRMATION SYSTEMGen-Probe, Inc.1986-07-021210

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