Cleared Traditional

K833692 - FRASER HARLAKE DENTAL ANTI-POLUTION SYS

K833692 is an FDA 510(k) clearance for FRASER HARLAKE DENTAL ANTI-POLUTION SYS, manufactured by Fraser Harlake, Inc.. The device is a Class 2 Anesthesiology device with product code CBN cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K833692 · Fraser Harlake, Inc. · Anesthesiology device
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Nov 1983
Decision
42d
Days
Class 2
Risk

K833692 is an FDA 510(k) clearance for the FRASER HARLAKE DENTAL ANTI-POLUTION SYS. Classified as Apparatus, Gas-scavenging (product code CBN), Class II - Special Controls.

Submitted by Fraser Harlake, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 29, 1983 after a review of 42 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fraser Harlake, Inc. devices

FDA 510(k) Submission Details - K833692

510(k) Number K833692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1983
Decision Date November 29, 1983
Days to Decision 42 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 140d · This submission: 42d
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 K833692.
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