Cleared Traditional

K800503 - SUCTION CATHETER

K800503 is an FDA 510(k) clearance for SUCTION CATHETER, manufactured by Medi-Craft , Ltd.. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K800503 · Medi-Craft , Ltd. · Anesthesiology device
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Mar 1980
Decision
14d
Days
Class 1
Risk

K800503 is an FDA 510(k) clearance for the SUCTION CATHETER. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Medi-Craft , Ltd. (Mchenry, US). The FDA issued a Cleared decision on March 18, 1980 after a review of 14 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.

FDA 510(k) Submission Details - K800503

510(k) Number K800503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1980
Decision Date March 18, 1980
Days to Decision 14 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 140d · This submission: 14d
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 72
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K800503.
HYDROPHILIC COATED CATHETER
K810023 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1981
CATHETER SUCTION TRACHEOBRONCHIAL
K801814 · Concord Laboratories, Inc. · Aug 1980
ARGYLE SAF-T-MARK SUCTION CATHETER
K801551 · Sherwood Medical Co. · Jul 1980
CONPHAR SUCTION CATHETER-W/0 CONTROL
K791253 · Conphar, Inc. · Jul 1979
VENT-O2-CATH
K760371 · Dryden Corp. · Aug 1976