Cleared Traditional

K170037 - Breathe Technologies Life2000 Ventilati...

K170037 is an FDA 510(k) clearance for Breathe Technologies Life2000 Ventilati..., manufactured by Breathe Technologies. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K170037 · Breathe Technologies · Anesthesiology device
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Aug 2017
Decision
219d
Days
Class 2
Risk

K170037 is an FDA 510(k) clearance for the Breathe Technologies Life2000™ Ventilation System. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Breathe Technologies (Irvine, US). The FDA issued a Cleared decision on August 11, 2017 after a review of 219 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 Breathe Technologies devices

FDA 510(k) Submission Details - K170037

510(k) Number K170037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2017
Decision Date August 11, 2017
Days to Decision 219 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
79d slower than avg
Panel avg: 140d · This submission: 219d
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 322
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