Cleared Traditional

K840431 - SCRATCH & SNIFF FOR ANESTHESIA

K840431 is the FDA 510(k) clearance for SCRATCH & SNIFF FOR ANESTHESIA by Dryden Corp.. It is a Class 1 Anesthesiology device (product code CAI) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K840431 · Dryden Corp. · Anesthesiology device
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May 1984
Decision
103d
Days
Class 1
Risk

K840431 is an FDA 510(k) clearance for the SCRATCH & SNIFF FOR ANESTHESIA. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Dryden Corp. (Mchenry, US). The FDA issued a Cleared decision on May 14, 1984 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5240 - 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 Dryden Corp. devices

Submission Details

510(k) Number K840431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1984
Decision Date May 14, 1984
Days to Decision 103 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 140d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5240
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)

All 25
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K840431.
PHARMASEAL ISOFLEX ANESTHESIA BREATHING CIRCUIT
K881141 · Baxter Healthcare Corp · Apr 1988
CIRCUIT ANES. BREATHING & COMPONENTS
K862003 · Vital Signs, Inc. · Jul 1986
CIRCUIT, ANES. BREATHING (NON-REBREATHING)
K861438 · Vital Signs, Inc. · May 1986
VOLUME VENTILATOR CIRCUIT-NEBULIZER
K833196 · Airlife, Inc. · Nov 1983
SPIROMETER ISOLATION VALVE #8890
K833088 · Boehringer Mannheim Corp. · Oct 1983
POSITIVE CLOSURE ANESTHETIC VALVE
K811015 · Orthopedic Systems, Inc. · May 1981