Cleared Traditional

BIPAP FOCUS (K053168) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K053168 · Respironics (Ireland) Limited · Anesthesiology device
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Jan 2006
Decision
51d
Days
Class 2
Risk

K053168 is an FDA 510(k) clearance for the BIPAP FOCUS. Classified as Ventilator, Continuous, Non-life-supporting (product code MNS), Class II - Special Controls.

Submitted by Respironics (Ireland) Limited (Galway, IE). The FDA issued a Cleared decision on January 4, 2006 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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 Respironics (Ireland) Limited devices

Submission Details

510(k) Number K053168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2005
Decision Date January 04, 2006
Days to Decision 51 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
89d faster than avg
Panel avg: 140d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNS Ventilator, Continuous, Non-life-supporting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - MNS Ventilator, Continuous, Non-life-supporting

All 36
Devices cleared under the same product code (MNS) and FDA review panel - the closest regulatory comparables to K053168.
BIPAP AUTOSV
K063540 · Respironics, Inc. · Feb 2007
BIPAP SYNCHRONY
K063533 · Respironics, Inc. · Feb 2007
VPAP III ST-A/KIDSTA MASK SYSTEM
K060105 · Resmed, Ltd. · Apr 2006
VPAP ADAPT
K051364 · Resmed, Ltd. · Aug 2005
VPAP III ST-A
K033276 · Resmed, Ltd. · Jun 2004
BIPAP HARMONY VENTILATORY SUPPORT SYSTEM
K031656 · Respironics, Inc. · Jul 2003