Cleared Traditional

K863653 - SUCTION-OFF

K863653 is an FDA 510(k) clearance for SUCTION-OFF, manufactured by B&B Medical Technologies, Inc.. The device is a Class 1 General & Plastic Surgery device with product code HXD cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K863653 · B&B Medical Technologies, Inc. · General & Plastic Surgery device
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Oct 1986
Decision
19d
Days
Class 1
Risk

K863653 is an FDA 510(k) clearance for the SUCTION-OFF. Classified as Clamp (product code HXD), Class I - General Controls.

Submitted by B&B Medical Technologies, Inc. (Orangevale, US). The FDA issued a Cleared decision on October 7, 1986 after a review of 19 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 B&B Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K863653

510(k) Number K863653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1986
Decision Date October 07, 1986
Days to Decision 19 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 115d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

HXD Device Classification - Class 1, General Controls

Product Code HXD Clamp
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - HXD Clamp

All 8
Devices cleared under the same product code (HXD) and FDA review panel - the closest regulatory comparables to K863653.
INTESTINAL CLAMP
K890372 · Kinetic Medical Products · Feb 1989
PARAMETRIUM CLAMP
K890381 · Kinetic Medical Products · Feb 1989
C CLAMP
K872386 · Med-Tool, Inc. · Jul 1987
CANNULA CLAMP
K853538 · Cp Medical · Sep 1985
CLAMP, DISPOSABLE
K782090 · Concord Laboratories, Inc. · Dec 1978
CARPENTER BONE CLAMP
K770118 · Stryker Corp. · Jan 1977