Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

GWC — Predicate Candidate Screening

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

69 daysmedian FDA review time

142 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K884966	BACTIGEN(R) S. PNEUMONIAE	Armkel, LLC	1989-02-07	69
K884965	BACTIGEN(R) MENINGITIDIS PANEL	Armkel, LLC	1989-02-07	69
K870029	IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE	American Micro Scan	1987-03-25	79
K862848	LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110	Lkb Instruments, Inc.	1986-12-18	142
K842239	VENTRESCREEN STREP A TEST	Ventrex Laboratories, Inc.	1984-07-02	27
K841376	WELLCOGEN S. PNEUMONIAE	Wellcome Diagnostics	1984-05-02	29
K831887	BACTIGEN S. PNEUMONIAE	Armkel, LLC	1983-09-26	105
K821960	BBL PNEUMOSLIDE TEST	Bd Becton Dickinson Vacutainer Systems Preanalytic	1982-07-30	29
K802337	PHADEBACT PNEUMOCOCCUS TEST	Pharmacia, Inc.	1980-10-31	35

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