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

Panmed, Inc. — Predicate Candidate Screening

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

32 daysmedian FDA review time

46 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K852767	ERYTHOCYTE CREATINE	Panmed, Inc.	1986-11-13	503
K820642	SICKLE-CHECK	Panmed, Inc.	1982-04-14	37
K802154	REAGENTS USED-QUAN. MEASURE OF SERUM	Panmed, Inc.	1980-10-10	32
K802164	8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM.	Panmed, Inc.	1980-10-10	32
K802163	CHLORIDE COLOR & CHLORIDE SAMPLE DILUENT	Panmed, Inc.	1980-10-10	32
K802156	REAGENTS SERUM CREATINE USING TECHICON	Panmed, Inc.	1980-10-10	32
K802159	AMMONIUM MOLYBDATE INORGANIC PHOSPHORUS	Panmed, Inc.	1980-10-10	32
K802158	POSTASSIUM BUFFER SOL. & WASH SOLUTION	Panmed, Inc.	1980-10-10	32
K802155	REAGENTS SERUM SODIUM USING THE TECH.	Panmed, Inc.	1980-10-10	32
K802160	BUN COLOR REAGENT & BUN ACID USED	Panmed, Inc.	1980-10-10	32
K802162	CO2 COLOR REAGENT & CO2 SAMPLE DILUENT	Panmed, Inc.	1980-10-10	32
K802157	BCG REAGENT SERUM ALBUMIN W/TECHNICON	Panmed, Inc.	1980-10-10	32
K802161	BIURET REAGENT & TOTAL PROTEIN BLANK SOL	Panmed, Inc.	1980-10-10	32
K792347	MICRO LOWRY PROTEINTEST	Panmed, Inc.	1979-12-06	17
K792346	TWO MINUTE PROTEINTEST	Panmed, Inc.	1979-12-06	17
K780542	ALFATEST	Panmed, Inc.	1978-05-19	46

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