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

Empi — Predicate Candidate Screening

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

76 daysmedian FDA review time

223 days90th percentile

60clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K093324	EMPI CONTINUUM	Empi	2010-03-05	133	0
K090922	EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR	Empi	2009-06-05	65	0
K072946	HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM	Empi	2007-11-16	30	0
K070427	DUPEL TRANSPORT IONTOPHORESIS SYSTEM	Empi	2007-05-14	90	0
K061650	SELECT TENS, MODEL 4600S	Empi	2007-01-22	223	0
K041920	INFINITY PLUS ELECTROTHERAPY SYSTEM	Empi	2005-01-21	189	0
K042057	INFINITY ELECTROTHERAPY SYSTEM	Empi	2004-12-17	140	0
K030395	EMPI ACTION PATCH IONTOPHORESIS SYSTEM	Empi	2003-04-08	62	0
K021100	300 PV COMPLETE ELECTROTHERAPY SYSTEM	Empi	2002-06-18	75	0
K991991	DUPEL IONTOPHORESIS SYSTEM	Empi	1999-09-10	88	0
K983484	DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE	Empi	1998-12-28	84	0
K983206	SMALL VAGINAL/RECTAL ELECTRODE	Empi	1998-11-03	50	0
K972054	INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMA	Empi	1997-08-14	73	0
K971527	INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYST	Empi	1997-06-30	63	0
K970491	DUPEL II BUFFERED IONTOPHORESIS ELECTRODES	Empi	1997-05-30	109	0
K970307	MINNOVA PELVIC FLOOR STIMULATION SYSTEM	Empi	1997-04-22	85	0
K970203	EPIX VT	Empi	1997-04-14	83	0
K964577	INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFOR	Empi	1997-01-24	71	0
K951951	FOCUS MODEL 795 UNIT	Empi	1996-05-17	387	0
K954272	INNOVA RECTAL STIMULATON ELECTRODE	Empi	1996-04-15	216	0
K951903	EPIX XL TENS UNIT	Empi	1996-03-20	331	0
K952688	INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE	Empi	1995-12-06	177	0
K941911	INNOVA PELVIC FLOOR STIMULATION SYSTEM	Empi	1995-01-20	276	0
K940091	INNOVA VAGINAL EMG SENSING ELECTRODE	Empi	1994-12-29	356	0
K941389	EMPI TAPE PATCHES	Empi	1994-08-23	154	0
K915444	DUPEL IONTOPHORESIS DEVICE	Empi	1994-07-15	953	0
K912015	TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3	Empi	1991-11-15	193	0
K912014	TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODES MDL. 2	Empi	1991-10-28	175	0
K910081	TBD	Empi	1991-07-15	187	0
K903093	IONTOPHORESIS DEVICE	Empi	1990-10-11	90	0
K902195	TBD TENS REUSABLE ELECTRODE	Empi	1990-06-08	23	1
K901103	MODIFIED ISLAND SNAP TENS DISPOSABLE ELECTRODE	Empi	1990-03-23	16	0
K901102	MODIFIED ISLAND PIN TENS DISPOSABLE ELECTRODE	Empi	1990-03-23	16	0
K896703	TBD IONTOPHORESIS ELECTRODE	Empi	1990-02-26	90	0
K896485	MODIFIED ISLAND TENS DISP. ELECTRODE FOR SNAP CONN	Empi	1989-12-21	38	0
K890604	EMPI, MODEL 489, TENS	Empi	1989-06-01	115	0
K890614	EMPI MULTIDAY TENS DISPOSABLE ELECTRODE	Empi	1989-03-16	37	0
K890747	EMPI REUSEABLE PIN-STYLE TENS ELECTRODE	Empi	1989-03-16	31	0
K890605	EMPI ISLAND TENS ELECTRODE	Empi	1989-03-16	38	0
K882631	EMPI MODEL 727,NMS	Empi	1988-09-22	87	0
K881114	EMPI MODEL 989, TENS	Empi	1988-04-15	31	0
K870168	EMPI LOGIX MODEL 712 NMS, TENS	Empi	1987-04-01	77	0
K864010	EMPI MODEL 712, LOGIX(TM), NMS	Empi	1986-12-02	48	0
K862231	EMPI, MODEL 1000 HAND HELD ELECTRODE	Empi	1986-08-27	77	0
K861830	EMPI MODEL GLS 450, TENS	Empi	1986-07-15	63	0
K861451	EMPI MODEL 720 NMS, TENS	Empi	1986-07-03	76	0
K854775	EMPI MODEL 730 NMS	Empi	1986-02-12	75	0
K854774	EMPI MODEL 720 NMS	Empi	1986-02-12	75	0
K854513	EMPI, NMS/SUE CUTANEOUS ELECTRODE	Empi	1985-12-06	24	0
K851331	EMPI MODEL 100, CPM(POWER EXCERISE EQUIPMENT)	Empi	1985-07-17	104	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