Cleared Special

K001315 - MODIFICATION TO KION ANESTHESIA SYSTEM

K001315 is an FDA 510(k) clearance for MODIFICATION TO KION ANESTHESIA SYSTEM, manufactured by Siemens Elema AB. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Special 510(k) pathway after a 30-day FDA review.

K001315 · Siemens Elema AB · Anesthesiology device
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May 2000
Decision
30d
Days
Class 2
Risk

K001315 is an FDA 510(k) clearance for the MODIFICATION TO KION ANESTHESIA SYSTEM. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Siemens Elema AB (Danvers, US). The FDA issued a Cleared decision on May 26, 2000 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Siemens Elema AB devices

FDA 510(k) Submission Details - K001315

510(k) Number K001315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2000
Decision Date May 26, 2000
Days to Decision 30 days
Submission Type Special
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
110d faster than avg
Panel avg: 140d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

BSZ Device Classification - Class 2, Special Controls

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
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 - BSZ Gas-machine, Anesthesia

All 110
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K001315.
SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE
K003663 · Spacelabs Medical, Inc. · Jun 2001
NARKOMED MRI-2, MODEL NM-MRI-2
K003579 · Draeger Medical, Inc. · Jan 2001
NARKOMED MRI , NM-MRI
K001488 · Draeger Medical, Inc. · Jun 2000
DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR
K000706 · Datex-Ohmeda, Inc. · May 2000
DATES-OHMEDA AESTIVA SMARTVENT MRI
K993410 · Datex-Ohmeda, Inc. · Apr 2000
KION ANESTHESIA SYSTEM
K973971 · Siemens Medical Solutions USA, Inc. · Sep 1999