Cleared Traditional

K163292 - Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford

K163292 is an FDA 510(k) clearance for Sonic Block Tuohy, manufactured by Spectra Medical Devices. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K163292 · Spectra Medical Devices · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
290d
Days
Class 2
Risk

K163292 is an FDA 510(k) clearance for the Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Spectra Medical Devices (Wilmington, US). The FDA issued a Cleared decision on September 8, 2017 after a review of 290 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K163292

510(k) Number K163292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2016
Decision Date September 08, 2017
Days to Decision 290 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 140d · This submission: 290d
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.

Regulatory Consultant

Spectral Medical Devices, Inc.
Kathy Dassler

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BSP Needle, Conduction, Anesthetic (w/wo Introducer)

All 129
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K163292.
IMD's Lumbar Puncture Needle
K170112 · International Medical Development, Inc.(Imd) · Feb 2018
EchoGlo Needle
K171968 · Smiths Medical Asd, Inc. · Jan 2018
Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles
K171518 · Zhejiang Kindly Medical Devices Co., Ltd. · Jan 2018
NerveGuard NRFit, NerveGuard LUER
K170435 · PAJUNK GmbH Medizintechnologie · Jul 2017
Pinpoint GT Needles
K163216 · C.R. Bard, Inc. · Jun 2017
Entellus Medical Reinforced Anesthesia Needle
K163435 · Entellus Medical, Inc. · Apr 2017