# K243639: Portare System (FA-001)

- Pathway: 510(k) (Traditional)
- Applicant: Grumpy Innovation, Inc.
- Decided: Jun 5, 2025 after 192 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: 6 generations back to K931154 (1993). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181286: Ambu aScope RLS Slim, Ambu A/S (2018) Summary page 5.

## Indications for use
The Grumpy Innovation PORTARE System is intended for endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is intended to provide visualization via a monitor. The endoscope is intended for use in a hospital or clinical environment. It is intended for use in adults.

Source page: https://510kreport.com/device/K243639
Methodology: https://510kreport.com/methodology