# K152356: Sapphire

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Jan 8, 2016 after 141 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: 10 generations back to K971260 (1997). 51 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140054: Rescan, Resmed, Ltd. (2014) Summary page 4.
- K132371: Easycare Online, Resmed, Ltd. (2013) Summary page 4.

## Most influential descendants
- K181053: Care Orchestrator (2019), 1 descendant of its own
- K242485: EveryWare (2025), 0 descendants of its own
- K201439: Ventilator, Non-continuous (Respirator) (2020), 0 descendants of its own
- K183226: Care Orchestrator Essence (2019), 0 descendants of its own

## Indications for use
Sapphire is intended to support clinicians by tracking data on patients who are prescribed compatible therapy devices in accordance with the intended use of those therapy devices. Sapphire provides remote patient data collection & viewing and is intended to be used by healthcare representatives (e.g., Physicians, Clinicians, Durable Medical Equipment providers) in conjunction with compatible non-life support therapy devices to adjust prescription and/or performance settings. Sapphire allows read-only access to patients. Sapphire is intended to be used in hospital, institutional, provider, and home care settings.

Source page: https://510kreport.com/device/K152356
Methodology: https://510kreport.com/methodology