Cleared Traditional

K112729 - BLEASE700/900 SERIES VENTILATORS

K112729 is an FDA 510(k) clearance for BLEASE700/900 SERIES VENTILATORS, manufactured by Spacelabs Healthcare. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K112729 · Spacelabs Healthcare · Anesthesiology device
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Jun 2012
Decision
265d
Days
Class 2
Risk

K112729 is an FDA 510(k) clearance for the BLEASE700/900 SERIES VENTILATORS. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Spacelabs Healthcare (Nederland, US). The FDA issued a Cleared decision on June 11, 2012 after a review of 265 days - an extended review 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: 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 Spacelabs Healthcare devices

FDA 510(k) Submission Details - K112729

510(k) Number K112729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2011
Decision Date June 11, 2012
Days to Decision 265 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
125d slower than avg
Panel avg: 140d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
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 - CBK Ventilator, Continuous, Facility Use

All 327
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K112729.
HAMILTON-C2
K121225 · Hamilton Medical AG · Nov 2012
NEWPORT AURA VENTILATOR
K121891 · Newport Medical Instruments, Inc. · Nov 2012
PERFORMAX PEDIATRIC SE TOTAL FACE MASK
K120639 · Respironics, Inc. · Jul 2012
HAMILTON-C1
K120574 · Hamilton Medical AG · May 2012
HAMILTON-T1
K120670 · Hamilton Medical AG · Apr 2012
UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR
K111473 · Impact Instrumentation, Inc. · Feb 2012