# K023683: Multi-Strap Full Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Engineered Medical Systems
- Decided: Dec 1, 2003 after 395 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 K936047 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982283: Whisperflow Oxygen Flow Generator - Adjustable Model WF 8500 Whisperflow Oxygen Flow Generator - Fixed Model WF 8530 WH, Caradyne, Ltd. (1999) Summary page 1.
- K961915: Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, Large, Respironics, Inc. (1996) Summary page 1.
- K982530: Sullivan Mirage Full Face Mask, Resmed, Ltd. (1998) Summary page 1.

## Indications for use
A patient interface accessory for use with CPAP and bi-level systems used in the treatment of adult OSA and / or ventilatory support. A minimum pressure of> 3.0 cm H 2 0 at the mask is required. Single patient, multi-use

Source page: https://510kreport.com/device/K023683
Methodology: https://510kreport.com/methodology