Cleared Traditional

K955149 - MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K955149 · Bio-Medical Devices, Inc. · General Hospital
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Jan 1996
Decision
72d
Days
Class 2
Risk

K955149 is an FDA 510(k) clearance for the MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL. Classified as Tube, Aspirating, Flexible, Connecting (product code BYY), Class II - Special Controls.

Submitted by Bio-Medical Devices, Inc. (Irvine, US). The FDA issued a Cleared decision on January 24, 1996 after a review of 72 days - a notably fast clearance cycle.

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: 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 Bio-Medical Devices, Inc. devices

Submission Details

510(k) Number K955149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1995
Decision Date January 24, 1996
Days to Decision 72 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
56d faster than avg
Panel avg: 128d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BYY Tube, Aspirating, Flexible, Connecting
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.