Cleared Traditional

K032056 - BILEVEL CPAP

K032056 is an FDA 510(k) clearance for BILEVEL CPAP, manufactured by Sunrise Medical. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K032056 · Sunrise Medical · Anesthesiology device
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Feb 2004
Decision
233d
Days
Class 2
Risk

K032056 is an FDA 510(k) clearance for the BILEVEL CPAP, MODEL 9055 SERIES. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Sunrise Medical (Somerset, US). The FDA issued a Cleared decision on February 20, 2004 after a review of 233 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sunrise Medical devices

FDA 510(k) Submission Details - K032056

510(k) Number K032056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2003
Decision Date February 20, 2004
Days to Decision 233 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 140d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BZD Ventilator, Non-continuous (respirator)

All 307
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K032056.
INVACARE POLARIS EX CPAP, MODEL ISP3000
K031064 · Invacare Corp. · Mar 2004
RESMED S8 PRIME CPAP SYSTEM
K033841 · Resmed, Ltd. · Mar 2004
BIPAP PRO 2 BI-LEVEL SYSTEM
K032834 · Respironics, Inc. · Mar 2004
C2 NASAL MASK
K033759 · Respironics, Inc. · Feb 2004
INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
K031745 · Sensor Medics Corp. · Feb 2004
APEX MEDICAL CPAP RT 21XX
K022650 · Apex Medical Corp. · Feb 2004