Cleared Traditional

K130171 - FLIGHT 60 VENTILATOR

K130171 is an FDA 510(k) clearance for FLIGHT 60 VENTILATOR, manufactured by Flight Medical Innovations , Ltd.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 439-day FDA review.

K130171 · Flight Medical Innovations , Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
439d
Days
Class 2
Risk

K130171 is an FDA 510(k) clearance for the FLIGHT 60 VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Flight Medical Innovations , Ltd. (Chalotte, US). The FDA issued a Cleared decision on April 8, 2014 after a review of 439 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Flight Medical Innovations , Ltd. devices

FDA 510(k) Submission Details - K130171

510(k) Number K130171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2013
Decision Date April 08, 2014
Days to Decision 439 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
299d slower than avg
Panel avg: 140d · This submission: 439d
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 262
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K130171.
CARESCAPE R860
K142679 · Datex-Ohmeda, Inc. · Jun 2015
ENGSTROM CARESTATION, ENGSTROM PRO
K140575 · Datex-Ohmeda, Inc. · Feb 2015
ASTRAL VENTILATOR
K133868 · Resmed, Ltd. · Jun 2014
PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM
K131252 · Covidien · Feb 2014
HAMILTON-MR1
K122438 · Hamilton Medical AG · Nov 2013
HAMILTON-G5
K131774 · Hamilton Medical AG · Oct 2013