# Holter-Hausner Intl.

- Location (FDA's records): Bridgeport, PA
- FDA decisions: 42 (1978–1988): 42 510(k) clearances
- Product codes: JXG (21), HXA (6), GYK (5), HAO (1), BZD (1), KNX (1), HXR (1), LFJ (1), GXR (1), LKG (1), KOB (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 4 (0 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Vygon Neuro: 2 (https://510kreport.com/company/vygon-neuro)
- W. L. Gore & Associates, Inc.: 1 (https://510kreport.com/company/w-l-gore-associates)
- Sophysa SA: 1 (https://510kreport.com/company/sophysa)

## Its most-cited devices
- K853365: H-H Fifth Ventricle (1985), cited by 2
- K820311: H-H Burr Hole Catheter Support (1982), cited by 1
- K800168: H-H Fifth Ventricle (1980), cited by 1

## Recent decisions
- K875287: H-H Flushing Reservoir (Jul 14, 1988)
- K874508: H-H External Ventricular Drainage Collection Bag (Jan 19, 1988)
- K872285: H-H Hunter Active Tendon Implant DC (Sep 28, 1987)
- K872293: H-H Hunter Active Tendon Implant BC (Sep 28, 1987)
- K872284: H-H Hunter Active Tendon Implant PC (Sep 28, 1987)
- K871351: H-H Harris Neonatal Nasal Cannula Set for Cpap (May 14, 1987)
- K870660: H-H External Ventricular Drain (Evd) Comp./Systems (May 1, 1987)
- K865075: H-H Subgaleal Trocar (Jan 13, 1987)

Source page: https://510kreport.com/company/holter-hausner-intl