Cleared Traditional

K844590 - POWER PACK 160 SIEMENS-ELEMA AB

K844590 is an FDA 510(k) clearance for POWER PACK 160 SIEMENS-ELEMA AB, manufactured by Siemens Elema AB. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 3-day FDA review.

K844590 · Siemens Elema AB · Anesthesiology device
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Nov 1984
Decision
3d
Days
Class 2
Risk

K844590 is an FDA 510(k) clearance for the POWER PACK 160 SIEMENS-ELEMA AB. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Siemens Elema AB (Schaumburg, US). The FDA issued a Cleared decision on November 29, 1984 after a review of 3 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 Siemens Elema AB devices

FDA 510(k) Submission Details - K844590

510(k) Number K844590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1984
Decision Date November 29, 1984
Days to Decision 3 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d faster than avg
Panel avg: 140d · This submission: 3d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

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 239
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K844590.
OHMEDA 7000 ELECTRONIC ANESTHESIA VENTILATOR
K851509 · Ohmeda Medical · Jul 1985
CONNECTION CABLE FOR SYNCHRONIZATION OF TWO SERVO
K850374 · Siemens Elema AB · Apr 1985
SERVO VENTILATOR 900D SIEMENS-ELEMA AB
K844912 · Siemens Elema AB · Dec 1984
MICROPROCESSOR 7200A VENTILATOR
K843424 · Puritan Bennett Corp. · Nov 1984
BEAR JET-150 VENTILATOR
K842688 · Bear Medical Systems, Inc. · Jul 1984
PENLON TRANSPORT VENTILATOR SERIES 350
K842362 · Bear Medical Systems, Inc. · Jun 1984