# K162611: PeriFLEX

- Pathway: 510(k) (Traditional)
- Applicant: Spiration, Inc.
- Decided: Feb 9, 2017 after 143 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- 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 K914181 (1991). 1 ancestor in all.
12 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914181: Wang/Mill-Rose Transbronchial Aspiration Needle, Mill-Rose Laboratory (1991) Summary page 4.

## Most influential descendants
- K173760: Monarch Endoscopy Platform (Monarch Platform) (2018), 7 descendants of its own
- K193534: Monarch Platform (2020), 5 descendants of its own
- K171232: PeriView FLEX (2017), 3 descendants of its own
- K211493: Monarch Platform (2021), 2 descendants of its own
- K243219: MONARCH™ Platform (MON-000008) (2025), 1 descendant of its own

## Indications for use
This device is intended to be used through a compatible bronchoscope for the collection of tissue from the intrapulmonary regions. Do not use for any purpose other than its intended use.

Source page: https://510kreport.com/device/K162611
Methodology: https://510kreport.com/methodology