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

Pharmaquest Corp. — Predicate Candidate Screening

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

39 daysmedian FDA review time

105 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K945519	FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URI	Pharmaquest Corp.	1995-11-03	359
K833880	TELEPHONIC RECEIVER R-10 EEG	Pharmaquest Corp.	1983-11-29	13
K833236	TELEPHONE TRANSMITTER T-10 EEG	Pharmaquest Corp.	1983-11-29	105
K830705	MINI LANCET-BLOOD LANCET	Pharmaquest Corp.	1983-04-08	32
K822976	HYPOCOUNT A	Pharmaquest Corp.	1982-11-16	39
K822486	HOME BLOOD GLUCOSE MONITOR	Pharmaquest Corp.	1982-11-05	80
K820248	RODDER VOLUME VENTILATOR	Pharmaquest Corp.	1982-04-16	77
K812849	PTT-200 TELEPHONIC PULMONARY TRANSMITT	Pharmaquest Corp.	1981-12-03	55
K812850	PTT-200 PULMONARY RECEIVER/MICROPROCES	Pharmaquest Corp.	1981-12-03	55
K813010	EEG TELEPHONE TRANSMITTER, MODEL #T-7	Pharmaquest Corp.	1981-11-16	20
K812683	NEONATE FLEXFLOAT	Pharmaquest Corp.	1981-10-13	21
K812682	FLEXFLOAT HEATER	Pharmaquest Corp.	1981-10-08	16
K812681	ADULT FLEX FLOAT W/HEATER	Pharmaquest Corp.	1981-10-08	16
K812684	ADULT FLEXFLOAT	Pharmaquest Corp.	1981-10-08	16

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