# K052249: Utopia

- Pathway: 510(k) (Traditional)
- Applicant: Respcare, Inc.
- Decided: Dec 7, 2005 after 111 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: 4 generations back to K936047 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030822: 7600 Series Multi-Patient Multi-Use Oro-Nasal Cpap/NPPV Masks, Hans Rudolph, Inc. (2003) Summary page 1.
- K040506: Flexifil Series HC431 Full Face Mask, Model HC431A, Fisher & Paykel Healthcare, Ltd. (2004) Summary page 1.
- K002465: Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876, Respironics, Inc. (2000) Summary page 1.

## Indications for use
The Utopia is intended for use by adults (>30 kg) as a patient interface for currently-marketed CPAP or Bi-Level positive-pressure ventilation devices for treatment of respiratory insufficiencies and obstructive sleep apnea. (Applies to the standard version): For homecare applications, the Utopia may be reused multiple times by a single patient. For institutional applications (i.e. hospital or other clinical settings), this interface may be reused multiple times by multiple patients. (Applies to the Disposable version): The Utopia Disposable is a single patient, single use interface.

Source page: https://510kreport.com/device/K052249
Methodology: https://510kreport.com/methodology