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

Phamatech, Inc. — Predicate Candidate Screening

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

58 daysmedian FDA review time

392 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K181945	QuickScreen Pro Multi Drug Screening Test, Model 9395Z	Phamatech, Inc.	2018-10-18	90
K131069	QUICKSCREEN AMPHETINE 500 TEST	Phamatech, Inc.	2014-05-14	392
K103295	QUICKSCREEN COCAINE 150 SCREENING TEST	Phamatech, Inc.	2012-02-01	450
K070009	AT HOME DRUG TEST MODELS, 9308T AND 9308X	Phamatech, Inc.	2007-12-07	338
K070098	QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 901	Phamatech, Inc.	2007-12-07	331
K043599	MOMENTS MENOPAUSE CHECK, MODEL 9113	Phamatech, Inc.	2005-02-25	58
K043051	QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 91	Phamatech, Inc.	2005-02-07	95
K043167	PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 902	Phamatech, Inc.	2004-12-29	43
K040575	PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112	Phamatech, Inc.	2004-05-20	77
K021409	AT HOME OVULATION TEST, MODEL 9032	Phamatech, Inc.	2002-05-24	21
K013407	AT HOME DRUG TEST, MODEL 9084	Phamatech, Inc.	2001-12-06	52
K013409	AT HOME DRUG TEST, MODEL 9074	Phamatech, Inc.	2001-12-06	52
K013410	AT HOME DRUG TEST, MODEL 9064	Phamatech, Inc.	2001-12-06	52
K013408	AT HOME DRUG TEST, MODEL 9079	Phamatech, Inc.	2001-12-06	52
K013412	AT HOME DRUG TEST, MODEL 9069	Phamatech, Inc.	2001-12-06	52

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