Cleared Traditional

K841480 - INFECTION CONTROL VALVE

K841480 is an FDA 510(k) clearance for INFECTION CONTROL VALVE, manufactured by Superior Plastic Products Corp.. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K841480 · Superior Plastic Products Corp. · Anesthesiology device
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Apr 1984
Decision
16d
Days
Class 1
Risk

K841480 is an FDA 510(k) clearance for the INFECTION CONTROL VALVE. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Superior Plastic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on April 25, 1984 after a review of 16 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 Superior Plastic Products Corp. devices

FDA 510(k) Submission Details - K841480

510(k) Number K841480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1984
Decision Date April 25, 1984
Days to Decision 16 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d faster than avg
Panel avg: 140d · This submission: 16d
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 K841480.
JINOTTI OXYGEN/SUCTION CATHETER
K841425 · Research Medical, Inc. · Sep 1984
AMER. PHARMASEAL NO TOUCH SATIN CATHET
K842198 · American Pharmaseal Div. Ahsc · Jun 1984
OXY-VAC
K842205 · Medi-Tech, Inc. · Jun 1984
TRACHEOSTOMY CLEANING TRAY
K840664 · American Pharmaseal Div. Ahsc · Mar 1984
IRRI-CATH
K833908 · Portex, Inc. · Feb 1984
BRONCHITRAC DF DUAL RESP/CATHETER
K833633 · Ackrad Laboratories · Dec 1983