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

JPD — Predicate Candidate Screening

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

69 daysmedian FDA review time

141 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K020489	G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE	Tosoh Medics, Inc.	2002-05-14	90	2
K991127	VARIANT II B-THALASSEMIA	Bio-Rad	1999-06-10	69	4
K924122	VARIANT BETA-THALASSEMIA SHORT PROGRAM	Bio-Rad	1993-03-11	209	3
K924496	GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT	Drew Scientific , Ltd.	1992-11-16	73	0
K923317	COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL	Helena Laboratories	1992-08-25	49	0
K923318	COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL	Helena Laboratories	1992-08-25	49	0
K913384	COLUMNMATE(TM) BETA-THAL CAT. NO. 4515	Helena Laboratories	1991-12-17	141	0
K896168	HEMOGLOBIN A2 MICRO COLUMN TEST	Bio-Rad	1990-01-18	85	0
K875102	DETER. OF HEMOGLOBIN A2 USING THE DIAMAT	Bio-Rad	1988-02-24	76	0
K823870	BETA THALQUIK COLUMN #5341	Helena Laboratories	1983-02-01	40	0
K812077	HELENA SICKLE-THAL QUIK COLUMN METHOD	Helena Laboratories	1981-08-18	27	0
K803108	HELENA HBA2 QUIK COLUMN METHOD	Helena Laboratories	1981-01-09	30	0
K801410	HEMOHLOBIN A2 CONTROL-LYOPHILIZED	Isolab, Inc.	1980-07-21	35	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