Cleared Traditional

K833147 - CENTRALERT

K833147 is an FDA 510(k) clearance for CENTRALERT, 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 92-day FDA review.

K833147 · Draeger Medical, Inc. · Anesthesiology device
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Dec 1983
Decision
92d
Days
Class 2
Risk

K833147 is an FDA 510(k) clearance for the CENTRALERT. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Draeger Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 16, 1983 after a review of 92 days - within the typical 510(k) review window.

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 - K833147

510(k) Number K833147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1983
Decision Date December 16, 1983
Days to Decision 92 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
48d faster than avg
Panel avg: 140d · This submission: 92d
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 K833147.
OHMEDA ANESTHESIA RECORD KEEPER
K844012 · Ohmeda Medical · Oct 1984
OHIO UNITROL II ANESTHESIA GAS MACHINE
K840356 · Ohio Medical Products · Apr 1984
BAG-TO-VENTILATOR SELECTOR VALVE
K841274 · Ohio Medical Products · Apr 1984
MODULUS II ANESTHESIA GAS MACHINE
K833335 · Ohio Medical Products · Nov 1983
AIR-SHIELDS VENTIMETER VENTILATOR-CONTR
K830680 · Narco Scientific · Apr 1983
NARKOMED 2A ANESTHESIA MACHINE
K822218 · Draeger Medical, Inc. · Sep 1982