Cleared Traditional

K884802 - CAVENDISH 460/680 ANESTHESIA MACHINE

K884802 is the FDA 510(k) clearance for CAVENDISH 460/680 ANESTHESIA MACHINE by Dentsply Intl.. It is a Class 2 Anesthesiology device (product code BSZ) cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K884802 · Dentsply Intl. · Anesthesiology device
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Aug 1989
Decision
257d
Days
Class 2
Risk

K884802 is an FDA 510(k) clearance for the CAVENDISH 460/680 ANESTHESIA MACHINE. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on August 1, 1989 after a review of 257 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 Dentsply Intl. devices

Submission Details

510(k) Number K884802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1988
Decision Date August 01, 1989
Days to Decision 257 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
117d slower than avg
Panel avg: 140d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 108
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K884802.
NARKOMED 2B ANESTHESIA SYSTEM
K900328 · Draeger Medical, Inc. · Feb 1990
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OHMEDA MODULUS CD ANESTHESIA SYSTEM
K894309 · Ohmeda Medical · Oct 1989
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K884991 · Datex Division Instrumentarium Corp. · Jun 1989
REVISED OHMEDA MODULUS II ANESTHESIA GAS MACHINE
K890410 · Ohmeda Medical · Apr 1989
REVISED PNEUMATIC DIAGRAMS FOR MODULUS II PLUS
K882489 · Ohmeda Medical · Jul 1988