# K222587: PatCom Distal Chip Endoscope

- Pathway: 510(k) (Traditional)
- Applicant: H&A Mui Enterprises, Inc.
- Decided: Jul 28, 2023 after 336 days
- Product code: EOB (Nasopharyngoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K991560 (1999). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132009: Cmos Video Nasopharyngoscope System, Schoelly Fiberoptic GmbH (2014) Summary page 4.

## Indications for use
The Patcom Distal Chip Endoscope is indicated when endoscopic visualization in the regions of mouth, nasal cavity, and upper airway is required.

Source page: https://510kreport.com/device/K222587
Methodology: https://510kreport.com/methodology