Cleared Traditional

K922843 - DYNAREX SUCTION CATHETERS & KITS

K922843 is an FDA 510(k) clearance for DYNAREX SUCTION CATHETERS & KITS, manufactured by Dynarex Corp.. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K922843 · Dynarex Corp. · Anesthesiology device
Download Printable Device Report (PDF)
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Jan 1993
Decision
213d
Days
Class 1
Risk

K922843 is an FDA 510(k) clearance for the DYNAREX SUCTION CATHETERS & KITS. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Dynarex Corp. (Brewster, US). The FDA issued a Cleared decision on January 11, 1993 after a review of 213 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6810 - 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 Dynarex Corp. devices

FDA 510(k) Submission Details - K922843

510(k) Number K922843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1992
Decision Date January 11, 1993
Days to Decision 213 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 140d · This submission: 213d
Pathway characteristics
Predicate-based equivalence.

BSY Device Classification - Class 1, General Controls

Product Code BSY Catheters, Suction, Tracheobronchial
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.6810
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 - BSY Catheters, Suction, Tracheobronchial

All 61
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K922843.
MULLY SUCTION STRAIGHT WITH FINGERTIP/WITH FUNNEL/WITH VACUTIP
K935553 · Puritas Health Care, Inc. · Jan 1994
ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM
K934723 · Sherwood Medical Co. · Nov 1993
ARGYLE ASPIR-FLEX SUCTION CATHETER
K925556 · Sherwood Medical Co. · Jul 1993
ARGYLE AERO-JET SUCTION CATHETER
K922148 · Sherwood Medical Co. · Dec 1992
STERILE MUCOUS SPECIMEN TRAP, DISPOSABLE
K923098 · Trinity Laboratories, Inc. · Sep 1992
MUCAID WITH SUCTION CATHETER AND EXTENSION TUBING
K910908 · Vygon Corp. · May 1991