Cleared Traditional

K943389 - SIDESTREAM PUMP PLUG-IN MODULE OF COMPONENT MONITORING SYSTEM

K943389 is an FDA 510(k) clearance for SIDESTREAM PUMP PLUG-IN MODULE OF COMPO..., manufactured by Hewlett-Packard Co.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K943389 · Hewlett-Packard Co. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
246d
Days
Class 2
Risk

K943389 is an FDA 510(k) clearance for the SIDESTREAM PUMP PLUG-IN MODULE OF COMPONENT MONITORING SYSTEM. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Waltham, US). The FDA issued a Cleared decision on March 17, 1995 after a review of 246 days - an extended review 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: 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.

View all Hewlett-Packard Co. devices

FDA 510(k) Submission Details - K943389

510(k) Number K943389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1994
Decision Date March 17, 1995
Days to Decision 246 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
106d slower than avg
Panel avg: 140d · This submission: 246d
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 241
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K943389.
SMART ANESTHESIA MULTI-GAS (SAM) MODULE
K950581 · Marquette Electronics, Inc. · Mar 1995
HEWLETT-PACKARD MODEL M1026A ANESTHETIC GAS MODULE
K951127 · Hewlett-Packard GmbH · Mar 1995
SMART ANESTHESIA MULTI-GAS (SAM) MODULE
K943977 · Marquette Electronics, Inc. · Mar 1995
HANDYPACK 911SC
K944541 · Pace Tech, Inc. · Feb 1995
9100 MUTIGAS MONITOR
K941971 · Bci Intl., Inc. · Nov 1994
COMET CAPNOGRAPH MODULE
K941165 · Spacelabs, Inc. · Oct 1994