Cleared Traditional

K170037 - Breathe Technologies Life2000™ Ventilation System

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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Coombs Medical Device Consulting, Inc.
Craig Coombs

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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All 435
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