Cleared Traditional

K051226 - AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER

K051226 is an FDA 510(k) clearance for AIRLIFE NASAL CONTINUOUS POSITIVE AIRWA..., manufactured by Cardinalhealth. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K051226 · Cardinalhealth · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
189d
Days
Class 2
Risk

K051226 is an FDA 510(k) clearance for the AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Cardinalhealth (Mcgaw Park, US). The FDA issued a Cleared decision on November 17, 2005 after a review of 189 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.

FDA 510(k) Submission Details - K051226

510(k) Number K051226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2005
Decision Date November 17, 2005
Days to Decision 189 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 140d · This submission: 189d
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 458
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K051226.
TREND 200 CPAP DEVICE, MODEL 5CP201
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BREATHEX OMEGA CPAP DEVICE, MODEL 322
K052597 · Hoffman Laboratories, LLC · Dec 2005
UTOPIA
K052249 · Respcare, Inc. · Dec 2005
TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050
K051583 · Tiara Medical Systems, Inc. · Nov 2005
RESPCARE FACE MASK
K052227 · Respcare, Inc. · Oct 2005
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K052110 · Respironics, Inc. · Oct 2005