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

Chester Labs, Inc. — Predicate Candidate Screening

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

261 daysmedian FDA review time

596 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K041060	E-Z LUBRICATING JELLY	Chester Labs, Inc.	2004-05-07	14
K001705	STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE	Chester Labs, Inc.	2000-06-29	24
K001593	MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIEL	Chester Labs, Inc.	2000-06-14	22
K944599	GRAHAM-FIELD CONDUCTIVE ECG SPRAY	Chester Labs, Inc.	1996-05-07	596
K944598	GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL	Chester Labs, Inc.	1996-05-07	596
K944600	GRAHAM-FIELD SALINE ELECTROLYTE GEL	Chester Labs, Inc.	1995-11-20	427
K944597	GRAHAM-FIELD ULTRASOUND SCANNING GEL	Chester Labs, Inc.	1995-06-21	275
K944596	GRAHAM-FIELD ULTRASOUND LOTION	Chester Labs, Inc.	1995-06-07	261
K940256	BIOSHIELD BLUE LATEX GLOVES	Chester Labs, Inc.	1994-03-23	61
K940254	BIOSHIELD BLUE POWDER FREE GLOVE	Chester Labs, Inc.	1994-03-23	61
K841871	LIQUA-SONIC GEL	Chester Labs, Inc.	1985-03-14	311

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