# K945199: RH2000 Real Ear Measurement System

- Pathway: 510(k) (Traditional)
- Applicant: Madsen Electronics, Inc.
- Decided: Apr 11, 1995 after 169 days
- Product code: EWO (Audiometer)
- Device class: 2
- Regulation: 21 CFR 874.1050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K113831: Primus Hearing Instrument Test Unit (2012), 1 descendant of its own
- K122028: Aurical Hit (2012), 0 descendants of its own
- K973320: Articulate Fitting System (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K945199
Methodology: https://510kreport.com/methodology