# K161686: F&P InfoSmart

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Jan 24, 2017 after 221 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K864318 (1987). 70 ancestors in all.
No later device cites it as a predicate yet.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110316: Infosend GSM, Fisher & Paykel Healthcare, Ltd. (2011) Summary page 4.

## Indications for use
InfoSmart™ is a software application for use with compatible Fisher & Paykel Healthcare OSA Flow generators. It allows for remote collection and management of device usage and therapeutic information. It also allows for remote therapy reporting and adjustment of device settings by a clinician.

Source page: https://510kreport.com/device/K161686
Methodology: https://510kreport.com/methodology