Cleared Traditional

K853435 - NARKOMED 3 ANESTHESIA SYSTEM

K853435 is an FDA 510(k) clearance for NARKOMED 3 ANESTHESIA SYSTEM, manufactured by Draeger Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K853435 · Draeger Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1986
Decision
160d
Days
Class 2
Risk

K853435 is an FDA 510(k) clearance for the NARKOMED 3 ANESTHESIA SYSTEM. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Draeger Medical, Inc. (Telford, US). The FDA issued a Cleared decision on January 22, 1986 after a review of 160 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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 Draeger Medical, Inc. devices

FDA 510(k) Submission Details - K853435

510(k) Number K853435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1985
Decision Date January 22, 1986
Days to Decision 160 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
20d slower than avg
Panel avg: 140d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K853435.
OHMEDA 'B' SERIES GAS DELIVERY SYSTEM
K863207 · Ohmeda Medical · Oct 1986
MODIFIED OHMEDA PAC PORTABLE ANESTHESIA SYSTEM
K862831 · Ohmeda Medical · Aug 1986
NARKOMED 3 ANESTHESIA SYSTEM (MODIFIED)
K861170 · Draeger Medical, Inc. · Apr 1986
ARI STANDARD ANESTHESIA RECORD
K854213 · Agilent Technologies, Inc. · Dec 1985
OHMEDA PAC PORTABLE ANESTHESIA SYSTEM
K850648 · Ohmeda Medical · Jul 1985
OHMEDA MDM ELECTRONIC-GAS MACHINE FOR ANALGESIA
K844849 · Ohmeda Medical · May 1985