Cleared Traditional

K043282 - DEVILBISS AUTOADJUST

K043282 is an FDA 510(k) clearance for DEVILBISS AUTOADJUST, 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 77-day FDA review.

K043282 · Sunrise Medical · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
77d
Days
Class 2
Risk

K043282 is an FDA 510(k) clearance for the DEVILBISS AUTOADJUST, MODEL 9054 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 11, 2005 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sunrise Medical devices

FDA 510(k) Submission Details - K043282

510(k) Number K043282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2004
Decision Date February 11, 2005
Days to Decision 77 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
63d faster than avg
Panel avg: 140d · This submission: 77d
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 K043282.
ULTRA MIRAGE II MASK
K050359 · Resmed, Ltd. · Mar 2005
SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM
K040202 · Salter Labs · Mar 2005
RESMED MERIDIAN MASK
K050142 · Resmed, Ltd. · Mar 2005
BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX
K043607 · Respironics, Inc. · Jan 2005
MIRAGE SWIFT
K042403 · Resmed, Ltd. · Oct 2004
HC604 CPAP HUMIDIFIER
K041900 · Fisher &Paykel Healthcare , Ltd. · Aug 2004