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

Hollister, Inc. · Predicate Candidate Screening

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

81 daysmedian FDA review time

152 days90th percentile

85clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K123804	INSTAFLO BOWEL CATHETER SYSTEM KIT	Hollister, Inc.	2013-04-17	128	0
K100273	INSTAFLO BOWEL CATHETER SYSTEM KIT	Hollister, Inc.	2010-04-22	83	0
K090960	VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122	Hollister, Inc.	2009-08-20	136	0
K083153	ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004,	Hollister, Inc.	2009-02-04	103	0
K050483	EVADRI BLADDER CONTROL SYSTEMS	Hollister, Inc.	2005-04-12	47	0
K040779	RESTORE WOUND CLEANSER	Hollister, Inc.	2004-05-17	52	0
K013612	INCARE PELVIC FLOOR THERAPY SYSTEM	Hollister, Inc.	2002-03-19	134	0
K013653	INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL	Hollister, Inc.	2002-03-05	119	0
K013483	INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CAT	Hollister, Inc.	2002-01-14	87	0
K013345	INCARE INTERMITTENT CATHETER	Hollister, Inc.	2002-01-07	90	0
K013141	MICROGYN PLUS STIMULATION DEVICE	Hollister, Inc.	2001-12-19	90	0
K011519	AMEDA HYGIENIKIT	Hollister, Inc.	2001-08-15	90	1
K991214	SIMPLICARE TRANSPARENT WOUND DRESSING	Hollister, Inc.	1999-10-14	188	0
K990456	ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP	Hollister, Inc.	1999-03-25	41	0
K980976	AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP	Hollister, Inc.	1998-08-21	158	0
K980209	SIMPLICARE THIN FILM WOUND DRESSINGS	Hollister, Inc.	1998-02-20	31	0
K974048	INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER	Hollister, Inc.	1997-12-23	60	0
K973023	INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET	Hollister, Inc.	1997-11-03	81	0
K971541	VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON	Hollister, Inc.	1997-06-25	58	0
K970602	VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL	Hollister, Inc.	1997-04-15	56	0
K970443	HOLLISTER RETRACTED PENIS POUCH	Hollister, Inc.	1997-02-25	20	0
K964006	INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES)	Hollister, Inc.	1996-12-31	85	0
K964057	INCARE HOT/ICE SYSTEM SHOULDER BLANKET	Hollister, Inc.	1996-12-31	83	0
K962537	INCARE HOT/ICE LITE MACHINE	Hollister, Inc.	1996-11-27	152	0
K963199	HEELBO PELVIC RESTRAINT	Hollister, Inc.	1996-11-01	78	0
K962963	CHECKMATE ANKLE RESTRAINT SYSTEM	Hollister, Inc.	1996-10-24	86	0
K962964	HEELBO JOHNNY GRAIT BELT SECURITY BELT	Hollister, Inc.	1996-10-24	86	0
K963222	MICROGYN PLUS STIMULATION DEVICE	Hollister, Inc.	1996-10-23	68	0
K963108	HEELBO QUILTED TORSO RESTRAINT	Hollister, Inc.	1996-10-09	58	0
K962900	SELF RETAINING MALE EXTERNAL URINARY CATHETER	Hollister, Inc.	1996-09-16	53	0
K961872	INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER	Hollister, Inc.	1996-08-09	86	0
K960311	PERINEOMETER	Hollister, Inc.	1996-04-18	87	0
K954621	RECLOSABLE WOUND COVER	Hollister, Inc.	1995-10-23	18	0
K930530	INCARE PRS 9300 PELVIC FL THERA SYST/TREAT URI INC	Hollister, Inc.	1995-10-17	987	0
K954235	HOLLISTER HYDROCOLLOID WOUND DRESSING	Hollister, Inc.	1995-10-06	25	0
K950531	EGNELL ELITE	Hollister, Inc.	1995-09-22	227	0
K953232	HOLLISTER NASOGASTRIC TUBE ATTACHMENT DEVICE	Hollister, Inc.	1995-08-18	39	0
K950933	HOLLISTER HYDROCOLLOID WOUND DRESSINGS	Hollister, Inc.	1995-07-11	132	0
K950176	PREMIE U-BAG URINE SPECIMEN COLLECTOR	Hollister, Inc.	1995-02-07	21	0
K944971	INCARE HOT/ICE COLD THERAPY COOLER	Hollister, Inc.	1995-01-30	111	0
K940269	HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER	Hollister, Inc.	1994-06-02	132	0
K941858	GEL CUSHION	Hollister, Inc.	1994-05-05	20	0
K931843	HOT/ICE SYSTEM STERILE CONFORMABLE/DISP. BLANKETS	Hollister, Inc.	1994-02-02	295	0
K912355	MOTHERS TOUCH ONE HAND BREAST PUMP	Hollister, Inc.	1993-12-10	927	1
K932855	HOLLISTER VERTICAL DRAIN/TUBE ATTACHMENT DEVICE	Hollister, Inc.	1993-10-13	125	0
K931277	HOLLISTER PREMIUM URINE COLLECTOR	Hollister, Inc.	1993-06-23	107	0
K926570	HOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 9878	Hollister, Inc.	1993-05-21	141	0
K922739	HOLLISTER HORIZONTAL DRAIN/TUBE ATTACHMENT DEVICE	Hollister, Inc.	1992-08-06	59	0
K915196	INCARE HOT/ICE SYSTEM 3	Hollister, Inc.	1992-02-03	76	0
K913035	INCARE HOT/ICE ABSORBENT INTERFACE	Hollister, Inc.	1991-09-25	78	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