Cleared Traditional

K832752 - COMFORT CUSHION DISPOS. ANALGESIS

K832752 is an FDA 510(k) clearance for COMFORT CUSHION DISPOS. ANALGESIS, manufactured by Mission Dental, Inc.. The device is a Class 2 Anesthesiology device with product code CBN cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K832752 · Mission Dental, Inc. · Anesthesiology device
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Dec 1983
Decision
115d
Days
Class 2
Risk

K832752 is an FDA 510(k) clearance for the COMFORT CUSHION DISPOS. ANALGESIS. Classified as Apparatus, Gas-scavenging (product code CBN), Class II - Special Controls.

Submitted by Mission Dental, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 8, 1983 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5430 - 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 Mission Dental, Inc. devices

FDA 510(k) Submission Details - K832752

510(k) Number K832752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1983
Decision Date December 08, 1983
Days to Decision 115 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 140d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBN Device Classification - Class 2, Special Controls

Product Code CBN Apparatus, Gas-scavenging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5430
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 - CBN Apparatus, Gas-scavenging

All 24
Devices cleared under the same product code (CBN) and FDA review panel - the closest regulatory comparables to K832752.
OHIO WASTE GAS SCAVENGING RESERVOIR
K841733 · Ohio Medical Products · Jul 1984
OHIO WASTE GAS SCAVENGING INTERFACE
K842003 · Ohio Medical Products · May 1984
SCAVENGER TUBING 19MM
K840849 · The Kendal Co. · Mar 1984
POSIVAC
K791127 · Vital Signs, Inc. · Jul 1979
NAD SCAVENGING RELIEF VALVE
K790333 · Draeger Medical, Inc. · Mar 1979
SH-1
K770344 · Delta Medical Industries · May 1977