Cleared Traditional

K811963 - VISITEC NEEDLE RANGE (ANESTHESIOLOGY)

K811963 is an FDA 510(k) clearance for VISITEC NEEDLE RANGE (ANESTHESIOLOGY), manufactured by Visitec Co.. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K811963 · Visitec Co. · Anesthesiology device
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Jul 1981
Decision
6d
Days
Class 2
Risk

K811963 is an FDA 510(k) clearance for the VISITEC NEEDLE RANGE (ANESTHESIOLOGY). Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Visitec Co. (Walker, US). The FDA issued a Cleared decision on July 16, 1981 after a review of 6 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5150 - the FDA anesthesiology and respiratory 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 Visitec Co. devices

FDA 510(k) Submission Details - K811963

510(k) Number K811963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1981
Decision Date July 16, 1981
Days to Decision 6 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
134d faster than avg
Panel avg: 140d · This submission: 6d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSP Device Classification - Class 2, Special Controls

Product Code BSP Needle, Conduction, Anesthetic (w/wo Introducer)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5150
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 Anesthesiology devices follow this clearance model.