Cleared Traditional

K903669 - GENESIS INSUFFLATING CATHETER

K903669 is an FDA 510(k) clearance for GENESIS INSUFFLATING CATHETER, manufactured by General Medical Co.. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K903669 · General Medical Co. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1990
Decision
30d
Days
Class 1
Risk

K903669 is an FDA 510(k) clearance for the GENESIS INSUFFLATING CATHETER. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by General Medical Co. (Atlanta, US). The FDA issued a Cleared decision on September 12, 1990 after a review of 30 days - a notably fast clearance 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: 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 General Medical Co. devices

FDA 510(k) Submission Details - K903669

510(k) Number K903669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1990
Decision Date September 12, 1990
Days to Decision 30 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 140d · This submission: 30d
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 70
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K903669.
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
STERI-CATH-DL
K902687 · Concord/Portex · Aug 1990
BUSSE BAC/SHIELD
K902297 · Busse Hospital Disposables, Inc. · Aug 1990
SUCTION CATHETER, STERILE
K902814 · Orion Life Systems, Inc. · Aug 1990