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

Holter-Hausner Intl. — Predicate Candidate Screening

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

29 daysmedian FDA review time

104 days90th percentile

42clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K875287	H-H FLUSHING RESERVOIR	Holter-Hausner Intl.	1988-07-14	198	0
K874508	H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG	Holter-Hausner Intl.	1988-01-19	78	0
K872285	H-H HUNTER ACTIVE TENDON IMPLANT DC	Holter-Hausner Intl.	1987-09-28	104	0
K872293	H-H HUNTER ACTIVE TENDON IMPLANT BC	Holter-Hausner Intl.	1987-09-28	104	0
K872284	H-H HUNTER ACTIVE TENDON IMPLANT PC	Holter-Hausner Intl.	1987-09-28	104	0
K871351	H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP	Holter-Hausner Intl.	1987-05-14	38	0
K870660	H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS	Holter-Hausner Intl.	1987-05-01	71	0
K865075	H-H SUBGALEAL TROCAR	Holter-Hausner Intl.	1987-01-13	15	0
K853437	H-H HUNTER TENDON ROD	Holter-Hausner Intl.	1985-10-16	62	0
K853436	H-H HUNTER PASSIVE TENDON IMPLANT	Holter-Hausner Intl.	1985-10-16	62	0
K853438	H-H HUNTER ACTIVE TENDON IMPLANT	Holter-Hausner Intl.	1985-09-30	46	0
K853371	H-H ATRIAL CATHETERS & PERITONEAL CATHETERS	Holter-Hausner Intl.	1985-09-18	37	0
K853370	H-H CATHETER PASSERS(TACL DESIGN	Holter-Hausner Intl.	1985-09-18	37	2
K853369	H-H FIXATION & JOINING CONNECTORS	Holter-Hausner Intl.	1985-09-11	30	0
K853367	H-H BURR HOLE CATHETER SUPPORT	Holter-Hausner Intl.	1985-09-11	21	0
K853366	H-H UNITIZED STANDARD SHUNT/RESERVOIR SHUNT	Holter-Hausner Intl.	1985-09-11	30	0
K853368	H-H SHUNT INTRODUCER	Holter-Hausner Intl.	1985-09-06	25	0
K853365	H-H FIFTH VENTRICLE	Holter-Hausner Intl.	1985-09-05	24	0
K853364	H-H RICKHAM TYPE RESERVOIR	Holter-Hausner Intl.	1985-09-05	24	0
K853363	H-H CRUCIFORM-SLIT VALVE	Holter-Hausner Intl.	1985-09-03	22	1
K853362	H-H SLOTTED VENTRICULAR CATHETER/SLOTTED CATHETER	Holter-Hausner Intl.	1985-09-03	22	3
K853361	H-H VENTRICULAR CATHETERS & RESERVOIRS	Holter-Hausner Intl.	1985-08-28	16	3
K853458	H-H SEXTON SCUP URINE MGMT. SYS	Holter-Hausner Intl.	1985-08-27	11	0
K843013	H-H TENDEON IMPLANT	Holter-Hausner Intl.	1985-04-17	260	0
K843158	SEXTON CYSTOTOMY URINE PUMP	Holter-Hausner Intl.	1984-10-04	55	0
K841553	H-H SHUNT PASSERS	Holter-Hausner Intl.	1984-05-14	28	0
K833672	HH SUBCUTANEOUS ACCESS PORT	Holter-Hausner Intl.	1984-03-06	140	0
K830894	H-H IN-LINE VALVED CATHETER 2 TYPES	Holter-Hausner Intl.	1983-04-08	18	0
K822048	H-H NERVE ROOT RETRACTOR	Holter-Hausner Intl.	1982-07-22	10	0
K821012	H-H ALIMENTATION CATHETERS	Holter-Hausner Intl.	1982-05-28	46	0
K820312	H-H RICKHAM TYPE RESERVOIR	Holter-Hausner Intl.	1982-03-01	24	0
K820311	H-H BURR HOLE CATHETER SUPPORT	Holter-Hausner Intl.	1982-02-24	19	0
K800168	H-H FIFTH VENTRICLE	Holter-Hausner Intl.	1980-01-31	6	0
K792639	H-H SHUNT INTRODUCER	Holter-Hausner Intl.	1979-12-31	11	0
K791075	H-H SLOTTED CATHETER-RESERVOIR	Holter-Hausner Intl.	1979-08-03	52	0
K791076	H-H SLOTTED VENTRICULAR CATHETER	Holter-Hausner Intl.	1979-08-03	52	0
K790849	H-H FIXATION AND JOINING CONNECTORS	Holter-Hausner Intl.	1979-05-11	8	0
K790126	VALVE, H-H CRUCIFORM SLIT	Holter-Hausner Intl.	1979-01-26	2	1
K782105	CATHETERS, H-H VENTRICULAR	Holter-Hausner Intl.	1979-01-15	27	0
K781943	TENDON ROD MODEL OR41PO3-6	Holter-Hausner Intl.	1978-12-04	17	0
K781768	CATHETERS, H-H ATRIAL AND PERITONEAL	Holter-Hausner Intl.	1978-11-14	29	0
K780320	PASSIVE TENDON IMPLANT	Holter-Hausner Intl.	1978-03-17	21	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