Cleared Traditional

K051857 - VEO MULTIGAS MONITOR FOR POCKET PC

K051857 is an FDA 510(k) clearance for VEO MULTIGAS MONITOR FOR POCKET PC, manufactured by Weissburg Associates. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K051857 · Weissburg Associates · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
69d
Days
Class 2
Risk

K051857 is an FDA 510(k) clearance for the VEO MULTIGAS MONITOR FOR POCKET PC, MODEL 400221. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Weissburg Associates (Madison, US). The FDA issued a Cleared decision on September 15, 2005 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - 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 Weissburg Associates devices

FDA 510(k) Submission Details - K051857

510(k) Number K051857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2005
Decision Date September 15, 2005
Days to Decision 69 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
71d faster than avg
Panel avg: 140d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCK Device Classification - Class 2, Special Controls

Product Code CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1400
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 - CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

All 180
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K051857.
CARBON DIOXIDE MONITOR, MODEL OLG-2800A
K062115 · Nihon Kohden America, Inc. · Dec 2006
DATEX-OHMEDA S/5 INTERFACE MODULE E-INT
K052880 · Ge Healthcare · Nov 2005
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES
K052582 · Ge Healthcare · Oct 2005
DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIES
K052167 · Ge Healthcare · Sep 2005
C-CO2 COLORIMETRIC CO2 INDICATOR
K050066 · Marquest Medical Products, Inc. · Mar 2005
SMART BITEBLOC
K042665 · Oridion Medical 1987 , Ltd. · Nov 2004