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

LER · Predicate Candidate Screening

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

41 daysmedian FDA review time

85 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K942192	THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS	Sigma Diagnostics, Inc.	1994-07-13	70	0
K905521	CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION	Microgenics Corp.	1990-12-26	19	0
K882570	TURBOX THEOPHYLLINE ASSAY	Unipath , Ltd.	1988-11-10	141	0
K864409	IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS	Sclavo, Inc.	1986-12-22	42	0
K863475	THEOFAST(TM) TEST PACKAGE	3M Company	1986-11-05	57	0
K842585	THEOPHYLLINE KIT FLUORESCENCE POLARIZA-	Windsor Laboratories, Inc.	1984-09-26	85	0
K840758	IMMPULSE THEOPHYLLINE ASSAY REAGENTS	Paragon Diagnostics, Inc.	1984-04-04	41	0
K833070	TDX THEOPHYLLINE	Abbott Laboratories	1983-11-14	67	1
K831514	AMWA TDA THEOPHYLLINE TEST	Miles Laboratories, Inc.	1983-06-30	49	0
K823576	COBAS STANDARD FOR TOTAL PROTEIN	Hoffmann-La Roche, Inc.	1983-01-07	32	0
K820397	AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM	American Diagnostic Corp.	1982-03-02	19	0
K813240	EMIT-AAD THEOPHYLLINE ASSAY	Syva Co.	1981-12-03	16	0
K812518	AMES TDA THEOPHYLLINE TEST	Miles Laboratories, Inc.	1981-09-23	21	0
K811856	FLUOROMATIC THEOPHYLLINE FIA	Bio-Rad	1981-07-10	9	0
K810943	AMES TDA THEOPHYLLINE TEST	Miles Laboratories, Inc.	1981-04-17	10	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