Cleared Traditional

K942274 - ORION SUCTION CATHETER KIT WITH STERILE...

K942274 is the FDA 510(k) clearance for ORION SUCTION CATHETER KIT WITH STERILE... by Regulatory & Marketing Services, Inc.. It is a Class 1 General & Plastic Surgery device (product code GBX) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K942274 · Regulatory & Marketing Services, Inc. · General & Plastic Surgery device
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Jun 1994
Decision
23d
Days
Class 1
Risk

K942274 is an FDA 510(k) clearance for the ORION SUCTION CATHETER KIT WITH STERILE SALINE. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Regulatory & Marketing Services, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on June 2, 1994 after a review of 23 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery 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 Regulatory & Marketing Services, Inc. devices

Submission Details

510(k) Number K942274 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received May 10, 1994
Decision Date June 02, 1994
Days to Decision 23 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 115d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GBX Catheter, Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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 - GBX Catheter, Irrigation

All 12
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