# K884046: Audioscan (TM) Real Ear Measurement System RM500

- Pathway: 510(k) (Traditional)
- Applicant: Etymonic Design, Inc.
- Decided: Feb 13, 1989 after 140 days
- Product code: ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems)
- Device class: 2
- Regulation: 21 CFR 874.3310
- 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; 1 cites 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
- K012306: Audioscan Verifit, Model VF-1 (2001), 2 descendants of its own
- K061104: Speechlink 100 Type 1053 (2006), 1 descendant of its own
- K110286: GN Otometrics Type 1053 Freefit (2011), 0 descendants of its own

Source page: https://510kreport.com/device/K884046
Methodology: https://510kreport.com/methodology