Cleared Traditional

K833908 - IRRI-CATH

K833908 is an FDA 510(k) clearance for IRRI-CATH, manufactured by Portex, Inc.. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K833908 · Portex, Inc. · Anesthesiology device
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Feb 1984
Decision
82d
Days
Class 1
Risk

K833908 is an FDA 510(k) clearance for the IRRI-CATH. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Portex, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 82 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 Portex, Inc. devices

FDA 510(k) Submission Details - K833908

510(k) Number K833908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1983
Decision Date February 04, 1984
Days to Decision 82 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 140d · This submission: 82d
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 60
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K833908.
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
BRONCHITRAC DF DUAL RESP/CATHETER
K833633 · Ackrad Laboratories · Dec 1983
ARGYLE SUCTION CATHETERS
K830709 · Sherwood Medical Co. · Mar 1983
SUCTION TUBES
K822724 · Exco, Inc. · Oct 1982