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

HZJ — Predicate Candidate Screening

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

22 daysmedian FDA review time

60 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K843427	GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6	Accra Laboratories, Inc.	1984-10-02	28
K842735	PAP STAIN EA-65	E K Ind., Inc.	1984-09-11	60
K842739	PAP STAIN, EA-36	E K Ind., Inc.	1984-09-11	60
K842738	PAP STAIN EA-50	E K Ind., Inc.	1984-08-17	35
K842736	PAP STAIN, OG-6	E K Ind., Inc.	1984-08-17	35
K840054	PAPANICOLAOU STAIN SYS HT40	Sigma Chemical Co.	1984-02-17	42
K822035	VOLU-SOL GILLS EA	Volu Sol Medical Industries	1982-08-03	22
K820027	MODIFIED EA 50	Surgipath	1982-02-04	30
K812086	EA 65	Surgipath	1981-08-13	22
K812087	EA 50	Surgipath	1981-08-13	22
K800325	VOLU-SOL HISTO./CYTO. STAIN MOD. #EA65	Volu Sol Medical Industries	1980-02-26	14
K800322	VOLU-SOL EA-50 STAIN	Volu Sol Medical Industries	1980-02-26	14
K781582	PAPANICOLAOU STAIN EA-36	Bioscientific	1978-10-10	22
K781588	PAPANICOLAOU STIAN OG-6	Bioscientific	1978-10-10	22
K781583	PAPANICOLAOU STAIN :EA-50:	Bioscientific	1978-10-10	22

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