Cleared Traditional

K841425 - JINOTTI OXYGEN/SUCTION CATHETER

K841425 is the FDA 510(k) clearance for JINOTTI OXYGEN/SUCTION CATHETER by Research Medical, Inc.. It is a Class 1 Anesthesiology device (product code BSY) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K841425 · Research Medical, Inc. · Anesthesiology device
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Sep 1984
Decision
160d
Days
Class 1
Risk

K841425 is an FDA 510(k) clearance for the JINOTTI OXYGEN/SUCTION CATHETER. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Research Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 13, 1984 after a review of 160 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 Research Medical, Inc. devices

Submission Details

510(k) Number K841425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1984
Decision Date September 13, 1984
Days to Decision 160 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 140d · This submission: 160d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 14
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K841425.
ARGYLE AERO-JET SUCTION CATHETER
K922148 · Sherwood Medical Co. · Dec 1992
RESPIRONICS SUCTIONEASY
K882017 · Respironics, Inc. · Jul 1988
SUCTION CATHETER KIT
K843076 · Travenol Laboratories, S.A. · Nov 1984
ARGYLE SUCTION CATHETERS
K830709 · Sherwood Medical Co. · Mar 1983
RADIATION STERILIZED SUCTION CATHETERS
K820109 · Travenol Laboratories, S.A. · Jan 1982
ARGYLE SUCTION CATHETERS
K812747 · Sherwood Medical Co. · Oct 1981