Cleared Traditional

K922148 - ARGYLE AERO-JET SUCTION CATHETER

K922148 is an FDA 510(k) clearance for ARGYLE AERO-JET SUCTION CATHETER, manufactured by Sherwood Medical Co.. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K922148 · Sherwood Medical Co. · Anesthesiology device
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Dec 1992
Decision
214d
Days
Class 1
Risk

K922148 is an FDA 510(k) clearance for the ARGYLE AERO-JET SUCTION CATHETER. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on December 7, 1992 after a review of 214 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 Sherwood Medical Co. devices

FDA 510(k) Submission Details - K922148

510(k) Number K922148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1992
Decision Date December 07, 1992
Days to Decision 214 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 140d · This submission: 214d
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 69
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K922148.
ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM
K934723 · Sherwood Medical Co. · Nov 1993
ARGYLE ASPIR-FLEX SUCTION CATHETER
K925556 · Sherwood Medical Co. · Jul 1993
DYNAREX SUCTION CATHETERS & KITS
K922843 · Dynarex Corp. · Jan 1993
STERILE MUCOUS SPECIMEN TRAP, DISPOSABLE
K923098 · Trinity Laboratories, Inc. · Sep 1992
MUCAID WITH SUCTION CATHETER AND EXTENSION TUBING
K910908 · Vygon Corp. · May 1991
MUCAID
K910909 · Vygon Corp. · May 1991