# K123821: Aio HD Otoscope

- Pathway: 510(k) (Traditional)
- Applicant: Blue Focus
- Decided: May 17, 2013 after 156 days
- Product code: ERA (Otoscope)
- Device class: 1
- Regulation: 21 CFR 874.4770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K904802 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943916: Videotoscope, Welch Allyn, Inc. (1994) Summary page 1.
- K904802: Video Otoscope, Jedmed Instrument Co. (1991) Summary page 1.

## Cited in the summary but kept off the family tree
- K031853: Dr.Camscope Video Otoscope. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Indications for use
MIO RD otoscope is used to provide images of the ear canal and tympanic membrane. The MIO HID otoscope can be used to allow a physician a clear and focused view of the ear canal or tympanic membrane on a computer or monitor screen.

Source page: https://510kreport.com/device/K123821
Methodology: https://510kreport.com/methodology