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

Mast Immunosystems — Predicate Candidate Screening

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

72 daysmedian FDA review time

205 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K934524	MAST CLA ALLERGY SYSTEM	Mast Immunosystems	1994-03-07	168
K926420	MAST CLA ALLERGY SYSTEM	Mast Immunosystems	1994-03-07	439
K914850	CHEMILUMINESCENT SYSTEM ALLERGAN SPECIFIC IGE	Mast Immunosystems	1991-12-09	42
K910292	MAST CLA ALLERGY SYSTEM	Mast Immunosystems	1991-04-05	72
K870966	TOTAL IGE MASTICK	Mast Immunosystems	1987-04-14	35
K844629	MAST LUMINESCENT ALLERGY SYSTEM	Mast Immunosystems	1985-04-12	136
K843694	MAST ALLERGY SYSTEM	Mast Immunosystems	1985-04-12	205
K841642	MAST LUMINESCENT ALLERGY SYS	Mast Immunosystems	1984-06-07	48
K834526	MAST INHALANT PROFILE	Mast Immunosystems	1984-04-04	105
K833969	MAST TOTAL IGE	Mast Immunosystems	1984-01-04	49
K833885	MAST INHALANT PROFILE	Mast Immunosystems	1984-01-04	56
K830164	DENSITOMETRIC INHALENT PROFILE SLLER	Mast Immunosystems	1983-03-01	42
K823593	INHALANT PROFILE-ALLERGEN-SPECIFIC IGE	Mast Immunosystems	1983-02-25	81

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