Hollister, Inc.

Mount Juliet, TN, US

HOLLISTER, INC. appears in FDA device records in Mount Juliet, TN. FDA records list 85 510(k) clearances between 1977-02-01 and 2013-04-17, no PMA records and one registered establishment. As of 2026-09-10, FDA records show no recalls for this company, and at least one establishment registration is current.

510(k) clearances: 85
PMA records: 0
Recall records: 0
Registered establishments: 1

510(k) clearance history

Showing 50 of 85

FDA records hold 85 510(k) clearances for Hollister, Inc. between 1977 and 2013. The busiest year on record is 1996, with 11. The most recent is 2013, with 1.

Clearances by year, as a table

510(k) clearance decisions for Hollister, Inc., by decision year
Year	Clearances
1977	2
1978	2
1979	4
1980	2
1981	6
1982	5
1986	3
1987	2
1988	2
1989	3
1990	3
1991	2
1992	2
1993	4
1994	3
1995	8
1996	11
1997	5
1998	2
1999	2
2001	2
2002	4
2004	1
2005	1
2009	2
2010	1
2013	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K123804	INSTAFLO BOWEL CATHETER SYSTEM KIT	KNT	Substantially Equivalent	2013-04-17
K100273	INSTAFLO BOWEL CATHETER SYSTEM KIT	KNT	Unknown	2010-04-22
K090960	VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,	GBM	Substantially Equivalent	2009-08-20
K083153	ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007	KNT	Unknown	2009-02-04
K050483	EVADRI BLADDER CONTROL SYSTEMS	KPI	Substantially Equivalent	2005-04-12
K040779	RESTORE WOUND CLEANSER	KMF	Substantially Equivalent	2004-05-17
K013612	INCARE PELVIC FLOOR THERAPY SYSTEM	HIR	Substantially Equivalent	2002-03-19
K013653	INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE	HIR	Substantially Equivalent	2002-03-05
K013483	INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT	KOD	Substantially Equivalent	2002-01-14
K013345	INCARE INTERMITTENT CATHETER	KOD	Substantially Equivalent	2002-01-07
K013141	MICROGYN PLUS STIMULATION DEVICE	KPI	Substantially Equivalent	2001-12-19
K011519	AMEDA HYGIENIKIT	HGY	Substantially Equivalent	2001-08-15
K991214	SIMPLICARE TRANSPARENT WOUND DRESSING	MGP	Substantially Equivalent	1999-10-14
K990456	ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP	KPI	Substantially Equivalent	1999-03-25
K980976	AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP	HDB	Substantially Equivalent	1998-08-21
K980209	SIMPLICARE THIN FILM WOUND DRESSINGS	MGP	Unknown	1998-02-20
K974048	INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER	KPI	Substantially Equivalent	1997-12-23
K973023	INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET	ILO	Substantially Equivalent	1997-11-03
K971541	VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON	KPI	Substantially Equivalent	1997-06-25
K970602	VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL	KPI	Substantially Equivalent	1997-04-15
K970443	HOLLISTER RETRACTED PENIS POUCH	EXI	Substantially Equivalent	1997-02-25
K964057	INCARE HOT/ICE SYSTEM SHOULDER BLANKET	ILO	Substantially Equivalent	1996-12-31
K964006	INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES)	ILO	Substantially Equivalent	1996-12-31
K962537	INCARE HOT/ICE LITE MACHINE	ILO	Substantially Equivalent	1996-11-27
K963199	HEELBO PELVIC RESTRAINT	FMQ	Substantially Equivalent	1996-11-01
K962964	HEELBO JOHNNY GRAIT BELT SECURITY BELT	FMQ	Substantially Equivalent	1996-10-24
K962963	CHECKMATE ANKLE RESTRAINT SYSTEM	FMQ	Substantially Equivalent	1996-10-24
K963222	MICROGYN PLUS STIMULATION DEVICE	KPI	Substantially Equivalent	1996-10-23
K963108	HEELBO QUILTED TORSO RESTRAINT	FMQ	Substantially Equivalent	1996-10-09
K962900	SELF RETAINING MALE EXTERNAL URINARY CATHETER	EXJ	Substantially Equivalent	1996-09-16
K961872	INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER	KPI	Substantially Equivalent	1996-08-09
K960311	PERINEOMETER	HIR	Substantially Equivalent	1996-04-18
K954621	RECLOSABLE WOUND COVER	FRO	Substantially Equivalent for Some Indications	1995-10-23
K930530	INCARE PRS 9300 PELVIC FL THERA SYST/TREAT URI INC	KPI	Substantially Equivalent	1995-10-17
K954235	HOLLISTER HYDROCOLLOID WOUND DRESSING	FRO	Substantially Equivalent	1995-10-06
K950531	EGNELL ELITE	HGX	Substantially Equivalent	1995-09-22
K953232	HOLLISTER NASOGASTRIC TUBE ATTACHMENT DEVICE	KNT	Substantially Equivalent	1995-08-18
K950933	HOLLISTER HYDROCOLLOID WOUND DRESSINGS	FRO	Substantially Equivalent	1995-07-11
K950176	PREMIE U-BAG URINE SPECIMEN COLLECTOR	FOC	Substantially Equivalent	1995-02-07
K944971	INCARE HOT/ICE COLD THERAPY COOLER	ILO	Substantially Equivalent for Some Indications	1995-01-30
K940269	HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER	EXJ	Substantially Equivalent	1994-06-02
K941858	GEL CUSHION	KIC	Substantially Equivalent	1994-05-05
K931843	HOT/ICE SYSTEM STERILE CONFORMABLE/DISP. BLANKETS	ILO	Substantially Equivalent	1994-02-02
K912355	MOTHERS TOUCH ONE HAND BREAST PUMP	HGY	Substantially Equivalent	1993-12-10
K932855	HOLLISTER VERTICAL DRAIN/TUBE ATTACHMENT DEVICE	KNT	Substantially Equivalent	1993-10-13
K931277	HOLLISTER PREMIUM URINE COLLECTOR	EXI	Substantially Equivalent	1993-06-23
K926570	HOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 9878	KNX	Substantially Equivalent	1993-05-21
K922739	HOLLISTER HORIZONTAL DRAIN/TUBE ATTACHMENT DEVICE	GBX	Substantially Equivalent	1992-08-06
K915196	INCARE HOT/ICE SYSTEM 3	ILO	Substantially Equivalent	1992-02-03
K913035	INCARE HOT/ICE ABSORBENT INTERFACE	FRO	Substantially Equivalent	1991-09-25

Registered establishments

FDA registered establishments for Hollister, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
2320961	3003172243	HOLLISTER, INC.	12011 VOLUNTEER BLVD, Mount Juliet, TN 37122 US	2026	CBH EXB EXD EXE EXG EYZ EZD EZP EZR EZS and 18 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain