Cleared Traditional

AUTOMOBILE LIGHTER POWER CORD (K060549) - FDA 510(k) Clearance

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

K060549 · Pulmonetic Systems, Inc. · Anesthesiology device
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May 2006
Decision
63d
Days
Class 2
Risk

K060549 is an FDA 510(k) clearance for the AUTOMOBILE LIGHTER POWER CORD. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Pulmonetic Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 4, 2006 after a review of 63 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 Pulmonetic Systems, Inc. devices

Submission Details

510(k) Number K060549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2006
Decision Date May 04, 2006
Days to Decision 63 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
77d faster than avg
Panel avg: 140d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 107
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K060549.
TRILOGY 202 VENTILATOR
K093905 · Respironics, Inc. · May 2010
TRILOGY 200 VENTILATOR
K093416 · Respironics, Inc. · Jan 2010
VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840
K063650 · Puritan Bennett Corp. · Feb 2007
MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION
K053388 · Puritan Bennett Corp. · Apr 2006
ESPRIT VENTILATOR, MODEL V1000
K034040 · Respironics, Inc. · Jan 2004
IMAGE3 SE DISPOSABLE FULL FACE MASK
K023135 · Respironics, Inc. · Jan 2003