# K991648: Reusable Contour II Nasal Mask

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: May 28, 1999 after 15 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: 2 generations back to K833786 (1983). 3 ancestors in all.
58 later devices descend from it; 9 cite it directly.
9 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951264: Bipap Model S/T-D, Respironics, Inc. (1996). Our OCR of the scanned summary read K951284, FDA’s number for R&D Batteries, Inc. Part Numbers 5137, 5140, 5142 and 5155 (R & D Batteries, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Respironics BiPAP S/T-D System”.

## Most influential descendants
- K071509: Bipap Synchrony 2 Ventilatory Support System (2007), 28 descendants of its own
- K092818: Bipap Avaps Ventilatory Support System (2010), 11 descendants of its own
- K092835: Comfortgel Nasal Mask (2010), 10 descendants of its own
- K071560: Provent Nasal Dilator, Model BR2 (2008), 10 descendants of its own
- K113053: Bipap a 30 Ventilatory Support System (2012), 8 descendants of its own

## Indications for use
The Respironics Reusable Contour II Nasal Mask is intended to provide an interface for application of Respironics bi-level or CPAP therapy to patients. For single patient use in the home or hospital/institutional environment. The mask is to be used on adult patients (>30kg) for whom bi-level or CPAP therapy has been prescribed using a Respironics bi-level or CPAP system.

Source page: https://510kreport.com/device/K991648
Methodology: https://510kreport.com/methodology