Cleared Traditional

K870698 - VAN-TEC PROSTATE BIOPSY NEEDLE

K870698 is an FDA 510(k) clearance for VAN-TEC PROSTATE BIOPSY NEEDLE, manufactured by Van-Tec, Inc.. The device is a Class 1 Physical Medicine device with product code KNN cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K870698 · Van-Tec, Inc. · Physical Medicine device
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Mar 1987
Decision
34d
Days
Class 1
Risk

K870698 is an FDA 510(k) clearance for the VAN-TEC PROSTATE BIOPSY NEEDLE. Classified as Components, Wheelchair (product code KNN), Class I - General Controls.

Submitted by Van-Tec, Inc. (Spencer, US). The FDA issued a Cleared decision on March 25, 1987 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3920 - the FDA physical medicine 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.

FDA 510(k) Submission Details - K870698

510(k) Number K870698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1987
Decision Date March 25, 1987
Days to Decision 34 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 116d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

KNN Device Classification - Class 1, General Controls

Product Code KNN Components, Wheelchair
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3920
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 - KNN Components, Wheelchair

All 63
Devices cleared under the same product code (KNN) and FDA review panel - the closest regulatory comparables to K870698.
WHEELS-OFF QUICK RELEASE AXLE SYSTEM
K883679 · Rolcontrol Products, Co., Inc. · Sep 1988
STOUTE'S ASSIST-SEAT WHEELCHAIR COMPONENT
K882253 · Stoute'S "Assist-Seat" Corp. · Jun 1988
LIFESTYLE SOF. CARE GEL CHAIR CUSHION
K882012 · Gaymar Industries, Inc. · May 1988
REDMAN UPHOLSTERY SERIES FOR WHEELCHAIRS
K870299 · Redman, Inc. · Feb 1987
(ROTH)SPIRAL ROTATING PROSTATIC BIOPSY NEEDLE
K863385 · Cook Urological, Inc. · Nov 1986
UPHOLSTERED BUCKET SEAT
K862887 · Mednet, Inc. · Aug 1986
K870698 · VAN-TEC PROSTATE BIOPSY NEEDLE
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