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

Henley Intl. — Predicate Candidate Screening

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

145 daysmedian FDA review time

463 days90th percentile

44clearances measured

K-number	Device	Applicant	Decided	Review days
K943449	NEUROLOGICAL DIAGNOSTIC DEVICES	Henley Intl.	1995-11-15	485
K926279	UPPER BODY EXERCISER	Henley Intl.	1994-05-05	507
K926278	STAIR CLIMBER	Henley Intl.	1994-05-05	507
K926287	EXERCISE BICYCLE	Henley Intl.	1994-03-22	463
K926314	HYDRA FITNESS MODEL 311 TOTAL POWER	Henley Intl.	1994-03-18	458
K926313	COMPUTERIZED TESTING AND EXERCISE SYSTEMS	Henley Intl.	1994-02-04	416
K915864	MONOTRODE CUTANEOUS ELECTRODE	Henley Intl.	1993-07-21	568
K922036	SONOPULS 591	Henley Intl.	1993-06-29	424
K926316	TRUE-TRAC, STRATUS	Henley Intl.	1993-03-24	99
K920983	SONOPULS 590	Henley Intl.	1993-03-09	372
K921828	TEAM-MC II	Henley Intl.	1992-09-22	159
K922020	ENDOMED 582	Henley Intl.	1992-09-22	145
K904377	ELECTROCONDUCTIVE MEDIA	Henley Intl.	1991-11-15	417
K905672	TEAM-MC	Henley Intl.	1991-10-15	301
K903828	SYNAPS (TM)	Henley Intl.	1991-01-18	150
K896817	MODEL T11 FLUIDOTHERAPY UNIT	Henley Intl.	1991-01-18	410
K900189	CURAPULS 403 DIATHERMY UNIT	Henley Intl.	1990-09-18	245
K901630	CHEMPAD(TM), ELECTROCONDUCTIVE MEDIA (882.1275)	Henley Intl.	1990-07-16	98
K896620	NEUROTENS	Henley Intl.	1990-04-26	156
K900419	CRYOTRON-UL30	Henley Intl.	1990-02-27	28
K895301	EMS 8100	Henley Intl.	1990-02-20	179
K894549	DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE	Henley Intl.	1990-02-09	204
K895166	TTS2500	Henley Intl.	1989-10-30	69
K895161	TTS2800	Henley Intl.	1989-10-30	69
K895334	TTS2600	Henley Intl.	1989-10-30	61
K895211	TTS2700 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR	Henley Intl.	1989-10-30	73
K884231	SURGICAL 'LASER' DRAPE	Henley Intl.	1989-04-20	195
K882643	AM TM SYRGICAL DRAPES	Henley Intl.	1989-03-03	249
K884348	MODIFIED JELTRODE(TM) ELECTRODES DEEMED	Henley Intl.	1988-12-15	62
K882169	SURGICAL DUCT CLAMP (VINE)	Henley Intl.	1988-06-17	24
K880699	ENDOMED CV405	Henley Intl.	1988-05-02	70
K870384	ENDOMED 433	Henley Intl.	1988-04-13	439
K871802	MODEL K210 AND K211 FLUIDOTHERAPY UNITS	Henley Intl.	1987-09-04	119
K872394	SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT	Henley Intl.	1987-09-03	83
K872393	SONOPULS 463, ULTRASOUND THERAPY EQUIPMENT	Henley Intl.	1987-07-23	41
K870515	DYNATRON 438	Henley Intl.	1987-06-16	131
K871107	VASOTRAIN 447	Henley Intl.	1987-05-29	71
K871112	PELTIERTHERAPY(C) HEAT/COLD TREATMENT	Henley Intl.	1987-05-06	48
K870666	OMEGA T100	Henley Intl.	1987-04-22	62
K870667	OMEGA T200	Henley Intl.	1987-04-22	62
K862855	CRAIG NASO-GASTRIC TUBE HOLDER	Henley Intl.	1986-11-04	98
K861956	JELTRODE	Henley Intl.	1986-06-26	37
K861248	CURAPULS 419 DIATHERMY UNIT	Henley Intl.	1986-05-30	58
K861247	CURAMED 402 DIATHERMY UNIT	Henley Intl.	1986-05-30	58

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