# K110316: Infosend GSM

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Aug 19, 2011 after 197 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: 13 generations back to K864318 (1987). 69 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081029: Sleepstyle 200 Auto Series HC254, Fisher & Paykel Healthcare, Ltd. (2008) Summary page 1.
- K083862: Medapps 2.0 Remote Patient Monitoring System, Medapps, Inc. (2009) Summary page 1.

## Most influential descendants
- K161686: F&P InfoSmart (2017), 0 descendants of its own

## Indications for use
The F&P InfoGSM is intended for home and clinical use as an accessory for the F&P ICON CPAP device. The F&P InfoGSM transmits patient compliance and efficacy data from the CPAP device and allows this data to be reviewed by a clinician. In addition, remote adjustment of CPAP device settings is possible. The InfoGSM is intended for use with F&P Healthcare ICON CPAP devices only and should not be connected to any other device. The F&P InfoGSM is intended for home and clinical use as an accessory for the F&P ICON CPAP device. The F&P InfoGSM transmits patient compliance and efficacy data from the CPAP device and allows this data to be reviewed by a clinician. In addition, remote adjustment of CPAP device settings is possible. The InfoGSM is intended for use with F&P Healthcare ICON CPAP devices only and should not be connected to any other device.

Source page: https://510kreport.com/device/K110316
Methodology: https://510kreport.com/methodology