Cleared Traditional

SMART BREATH RESPIRATORY COMPENSATION OPTION (K022919) - FDA 510(k) Clearance

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

K022919 · GE Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
15d
Days
Class 2
Risk

K022919 is an FDA 510(k) clearance for the SMART BREATH RESPIRATORY COMPENSATION OPTION. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on September 19, 2002 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight 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 GE Medical Systems devices

Submission Details

510(k) Number K022919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2002
Decision Date September 19, 2002
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 Radiology devices follow this clearance model.

Regulatory Peers - JAK System, X-ray, Tomography, Computed

All 429
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K022919.
LUNG NODULE ASSESSMENT AND COMPARISON OPTION
K023785 · Philips Medical Systems (Cleveland), Inc. · Feb 2003
CT CARDIAC FUNCTION ANALYSIS SOFTWARE, MODELS CSCF-001A AND CSCF-001B
K023760 · Toshiba America Medical Systems, In.C · Nov 2002
LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW
K023332 · GE Medical Systems · Oct 2002
LUNGCARE CT SOFTWARE PACKAGE
K022013 · Siemens Medical Solutions USA, Inc. · Jul 2002
CGS-31A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER. TSX-101A (AQUILION ADVANCE MULTI)
K022050 · Toshiba America Medical Systems, In.C · Jul 2002
SMARTSCORE 3.5
K020929 · GE Medical Systems · Apr 2002