Holter-Hausner Intl.

Mchenry, IL, US

Holter-Hausner Intl. appears in FDA device records in Mchenry, IL. FDA records list 42 510(k) clearances between 1978-03-17 and 1988-07-14, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 42
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 42 510(k) clearances for Holter-Hausner Intl. between 1978 and 1988. The busiest year on record is 1985, with 16. The most recent is 1988, with 2.

Clearances by year, as a table

510(k) clearance decisions for Holter-Hausner Intl., by decision year
Year	Clearances
1978	3
1979	6
1980	1
1982	4
1983	1
1984	3
1985	16
1987	6
1988	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K875287	H-H FLUSHING RESERVOIR	JXG	Substantially Equivalent	1988-07-14
K874508	H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG	JXG	Substantially Equivalent	1988-01-19
K872293	H-H HUNTER ACTIVE TENDON IMPLANT BC	HXA	Substantially Equivalent for Some Indications	1987-09-28
K872285	H-H HUNTER ACTIVE TENDON IMPLANT DC	HXA	Substantially Equivalent for Some Indications	1987-09-28
K872284	H-H HUNTER ACTIVE TENDON IMPLANT PC	HXA	Substantially Equivalent for Some Indications	1987-09-28
K871351	H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP	BZD	Substantially Equivalent	1987-05-14
K870660	H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS	JXG	Substantially Equivalent	1987-05-01
K865075	H-H SUBGALEAL TROCAR	GYK	Substantially Equivalent	1987-01-13
K853437	H-H HUNTER TENDON ROD		Substantially Equivalent	1985-10-16
K853436	H-H HUNTER PASSIVE TENDON IMPLANT	HXR	Substantially Equivalent	1985-10-16
K853438	H-H HUNTER ACTIVE TENDON IMPLANT	HXA	Substantially Equivalent for Some Indications	1985-09-30
K853371	H-H ATRIAL CATHETERS & PERITONEAL CATHETERS	JXG	Substantially Equivalent	1985-09-18
K853370	H-H CATHETER PASSERS(TACL DESIGN	GYK	Substantially Equivalent	1985-09-18
K853369	H-H FIXATION & JOINING CONNECTORS	JXG	Substantially Equivalent	1985-09-11
K853367	H-H BURR HOLE CATHETER SUPPORT	GXR	Substantially Equivalent	1985-09-11
K853366	H-H UNITIZED STANDARD SHUNT/RESERVOIR SHUNT	JXG	Substantially Equivalent	1985-09-11
K853368	H-H SHUNT INTRODUCER	GYK	Substantially Equivalent	1985-09-06
K853365	H-H FIFTH VENTRICLE	JXG	Substantially Equivalent	1985-09-05
K853364	H-H RICKHAM TYPE RESERVOIR	JXG	Substantially Equivalent	1985-09-05
K853363	H-H CRUCIFORM-SLIT VALVE	JXG	Substantially Equivalent	1985-09-03
K853362	H-H SLOTTED VENTRICULAR CATHETER/SLOTTED CATHETER	JXG	Substantially Equivalent	1985-09-03
K853361	H-H VENTRICULAR CATHETERS & RESERVOIRS	JXG	Substantially Equivalent	1985-08-28
K853458	H-H SEXTON SCUP URINE MGMT. SYS	KNX	Substantially Equivalent	1985-08-27
K843013	H-H TENDEON IMPLANT		Substantially Equivalent	1985-04-17
K843158	SEXTON CYSTOTOMY URINE PUMP	KOB	Substantially Equivalent	1984-10-04
K841553	H-H SHUNT PASSERS	GYK	Substantially Equivalent	1984-05-14
K833672	HH SUBCUTANEOUS ACCESS PORT	LKG	Substantially Equivalent	1984-03-06
K830894	H-H IN-LINE VALVED CATHETER 2 TYPES	JXG	Substantially Equivalent	1983-04-08
K822048	H-H NERVE ROOT RETRACTOR	HAO	Substantially Equivalent	1982-07-22
K821012	H-H ALIMENTATION CATHETERS	LFJ	Substantially Equivalent	1982-05-28
K820312	H-H RICKHAM TYPE RESERVOIR	JXG	Substantially Equivalent	1982-03-01
K820311	H-H BURR HOLE CATHETER SUPPORT	JXG	Substantially Equivalent	1982-02-24
K800168	H-H FIFTH VENTRICLE	JXG	Substantially Equivalent	1980-01-31
K792639	H-H SHUNT INTRODUCER	GYK	Substantially Equivalent	1979-12-31
K791076	H-H SLOTTED VENTRICULAR CATHETER	JXG	Substantially Equivalent	1979-08-03
K791075	H-H SLOTTED CATHETER-RESERVOIR	JXG	Substantially Equivalent	1979-08-03
K790849	H-H FIXATION AND JOINING CONNECTORS	JXG	Substantially Equivalent	1979-05-11
K790126	VALVE, H-H CRUCIFORM SLIT	JXG	Substantially Equivalent	1979-01-26
K782105	CATHETERS, H-H VENTRICULAR	JXG	Substantially Equivalent	1979-01-15
K781943	TENDON ROD MODEL OR41PO3-6	HXA	Substantially Equivalent	1978-12-04
K781768	CATHETERS, H-H ATRIAL AND PERITONEAL	JXG	Substantially Equivalent	1978-11-14
K780320	PASSIVE TENDON IMPLANT	HXA	Substantially Equivalent	1978-03-17

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

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

Verification record

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