# K160127: iCodeConnect

- Pathway: 510(k) (Traditional)
- Applicant: 3B Medical, Inc.
- Decided: Nov 10, 2016 after 295 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: 8 generations back to K971260 (1997). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093684: Easycare Online, Resmed, Ltd. (2010) Summary page 5.

## Indications for use
iCodeConnect, in conjunction with a Luna CPAP or Auto-CPAP device, is intended for use in treating obstructive sleep apnea (OSA) on adult patients (>30 kg). iCodeConnect is intended to augment the standard follow-up care of patients diagnosed with obstructive sleep apnea by displaying usage and therapeutic information that has been transmitted from the patient's Luna CPAP or Auto-CPAP therapy device located in the home to the clinician or healthcare professional. iCodeConnect also provides remote settings capabilities.

Source page: https://510kreport.com/device/K160127
Methodology: https://510kreport.com/methodology