Cleared Traditional

K923992 - POWER PACK 350/BATTERY PACK 351

K923992 is the FDA 510(k) clearance for POWER PACK 350/BATTERY PACK 351 by Siemens Medical Solutions USA, Inc.. It is a Class 2 Anesthesiology device (product code CBK) cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K923992 · Siemens Medical Solutions USA, Inc. · Anesthesiology device
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Apr 1993
Decision
246d
Days
Class 2
Risk

K923992 is an FDA 510(k) clearance for the POWER PACK 350/BATTERY PACK 351. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on April 13, 1993 after a review of 246 days - an extended review 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: 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 Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K923992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1992
Decision Date April 13, 1993
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.

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 197
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K923992.
PROPORTIONAL SOLENOID VALVE
K922102 · Puritan Bennett Corp. · Sep 1994
BIRD 8400TI ADULT VOLUME VENTILATOR
K930747 · Bird Products Corp. · Feb 1994
BIRD AVIAN PORT MILITARY VENT NSN 6530-01-374-8903
K933262 · Bird Products Corp. · Jul 1993
BIRD 8400ST ADULT VOLUME VENTILATOR
K921387 · Bird Products Corp. · Mar 1993
SERVO GRAPHICS
K923444 · Siemens Medical Solutions USA, Inc. · Mar 1993
BIRD GRAPHICS MONITOR
K920113 · Bird Products Corp. · Feb 1993