Cleared Traditional

K914601 - SUCTION CONNECTING TUBING

K914601 is an FDA 510(k) clearance for SUCTION CONNECTING TUBING, manufactured by Bemis Mfg. Co.. The device is a Class 2 General Hospital device with product code GCX cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K914601 · Bemis Mfg. Co. · General Hospital
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Feb 1992
Decision
119d
Days
Class 2
Risk

K914601 is an FDA 510(k) clearance for the SUCTION CONNECTING TUBING. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Bemis Mfg. Co. (Sheboygan Falls, US). The FDA issued a Cleared decision on February 7, 1992 after a review of 119 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Bemis Mfg. Co. devices

FDA 510(k) Submission Details - K914601

510(k) Number K914601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1991
Decision Date February 07, 1992
Days to Decision 119 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 129d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCX Device Classification - Class 2, Special Controls

Product Code GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered

All 54
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K914601.
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