Cleared Traditional

K840431 - SCRATCH & SNIFF FOR ANESTHESIA

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

K840431 · Dryden Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K840431

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 140d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

CAI Device Classification - Class 1, General Controls

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 116
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K840431.
SAMSON 1000 ANESTHESIA CIRCUIT
K842488 · J. H. Emerson Co. · Jul 1984
BABYSET TM & PAC TM -PULMONARY ASSIST
K841264 · Life Design Systems, Inc. · Jun 1984
REUSEABLE NON-CONDUCTIVE FIXED Y
K841455 · Dryden Corp. · Jun 1984
CIRCUIT BREATHING
K840740 · Marquest Medical Products, Inc. · Apr 1984
ANESTHESIA VENTILATOR CIRCUIT
K840850 · The Kendal Co. · Mar 1984
PEDIATRIC INTUBATION CIRCUIT
K840056 · Ackrad Laboratories · Feb 1984