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

Cadwell Laboratories, Inc. — Predicate Candidate Screening

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

202 daysmedian FDA review time

435 days90th percentile

46clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K061706	CADWELL EASYNET OXIMETER MODULE	Cadwell Laboratories, Inc.	2007-03-05	262	0
K061705	CADWELL EASYNET NASAL PRESSURE MODULE	Cadwell Laboratories, Inc.	2006-11-21	158	0
K042350	TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR	Cadwell Laboratories, Inc.	2004-11-03	65	0
K040986	CADWELL LIMB MOVEMENT MODULE	Cadwell Laboratories, Inc.	2004-07-01	77	0
K040932	EASYNET BODY POSITION MODULE	Cadwell Laboratories, Inc.	2004-07-01	83	0
K971214	KILOWIN	Cadwell Laboratories, Inc.	1998-06-11	435	0
K962457	TWO-CHANNEL PREAMPLIFIER	Cadwell Laboratories, Inc.	1997-01-13	202	0
K962455	FOUR-CHANNEL PREAMPLIFIER	Cadwell Laboratories, Inc.	1997-01-13	202	0
K962458	CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER	Cadwell Laboratories, Inc.	1997-01-13	202	0
K946094	CADWELL EASY AMBULATORY EEG	Cadwell Laboratories, Inc.	1995-09-12	272	0
K933796	EEG NEEDLE ELECTRODE	Cadwell Laboratories, Inc.	1994-12-29	512	0
K933808	EEG CUP ELECTRODE	Cadwell Laboratories, Inc.	1994-12-29	512	0
K933805	RING ELECTRODE	Cadwell Laboratories, Inc.	1994-12-19	502	0
K933801	ELECTRODE, CUTANEOUS	Cadwell Laboratories, Inc.	1994-10-21	443	0
K933802	CUTANEOUS ELECTRODE	Cadwell Laboratories, Inc.	1994-09-07	399	0
K933807	GROUND PLATE ELECTRODE	Cadwell Laboratories, Inc.	1994-07-26	356	0
K933803	DISPOSABLE TAB ELECTRODE	Cadwell Laboratories, Inc.	1994-07-08	338	1
K933799	TEN-20 CONDUCTIVE PASTE GEL	Cadwell Laboratories, Inc.	1994-05-27	296	0
K933797	OMNI PREP GEL	Cadwell Laboratories, Inc.	1994-05-17	286	0
K933795	CONCENTRIC EMG NEEDLE ELECTRODE	Cadwell Laboratories, Inc.	1994-04-22	261	0
K933806	MONOPOLAR EMG NEEDLE ELECTRODE	Cadwell Laboratories, Inc.	1994-04-22	261	0
K933798	NU-PREP GEL	Cadwell Laboratories, Inc.	1994-04-22	261	0
K933793	GROUND/REFERENCE NEEDLE ELECTRODE	Cadwell Laboratories, Inc.	1994-04-19	258	0
K933804	LECTRON II CONDUCTIVE GEL/CADWELL ELECTRODE GEL	Cadwell Laboratories, Inc.	1994-03-22	230	0
K932407	CADWELL EASY WRITER AND EASY READER	Cadwell Laboratories, Inc.	1994-03-22	308	0
K931428	CADWELL 6200 A	Cadwell Laboratories, Inc.	1993-06-22	88	0
K924723	CADWELL SIERRA	Cadwell Laboratories, Inc.	1993-03-23	183	0
K905059	HIGH SPEED MAGNETIC STIMULATOR	Cadwell Laboratories, Inc.	1991-09-18	314	0
K895081	PROMONTORY STIMULATING ELECTRODE	Cadwell Laboratories, Inc.	1989-11-09	87	0
K894276	CADWELL FREEDOM EEG DEVICE	Cadwell Laboratories, Inc.	1989-09-29	98	0
K880088	CADWELL EXCEL	Cadwell Laboratories, Inc.	1988-05-04	113	0
K872183	AMBULATORY EEG PLAYBACK	Cadwell Laboratories, Inc.	1987-07-21	43	0
K863175	EES 10 ELECTRODELESS ELECTRICAL STIMULATOR	Cadwell Laboratories, Inc.	1987-01-13	148	0
K860801	MODEL 8400 W/MODIFICATIONS (SPECTRUM 32)	Cadwell Laboratories, Inc.	1986-11-18	259	0
K862361	40-HZ AUDITORY EVOKED RESPONSE TEST	Cadwell Laboratories, Inc.	1986-09-17	86	0
K862363	INSERT EARPHONES	Cadwell Laboratories, Inc.	1986-09-17	86	0
K844707	QUANTUM 84	Cadwell Laboratories, Inc.	1985-05-21	169	0
K831231	LED GOGGLES	Cadwell Laboratories, Inc.	1983-05-16	31	0
K830770	CONTRAST SENSITIVITY EQUIPMENT	Cadwell Laboratories, Inc.	1983-04-28	48	0
K830771	CADWELL 8400	Cadwell Laboratories, Inc.	1983-04-12	32	0
K822214	CADWELL 7400	Cadwell Laboratories, Inc.	1982-09-24	60	0
K820254	GOLD FOIL ERG ELECTRODES	Cadwell Laboratories, Inc.	1982-04-09	67	0
K820031	CADWELL 5200	Cadwell Laboratories, Inc.	1982-02-04	29	0
K820040	SC-IT IMPEDANCE TESTER	Cadwell Laboratories, Inc.	1982-01-28	21	0
K800648	CADWELL 7200	Cadwell Laboratories, Inc.	1980-04-21	28	0
K791235	CADWELL 7000 ELECTROMYOGRAPH MACHINE	Cadwell Laboratories, Inc.	1979-08-16	41	0

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