Cleared Traditional

K170435 - NerveGuard NRFit

K170435 is the FDA 510(k) clearance for NerveGuard NRFit by PAJUNK GmbH Medizintechnologie. It is a Class 2 Anesthesiology device (product code BSP) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K170435 · PAJUNK GmbH Medizintechnologie · Anesthesiology device
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Jul 2017
Decision
149d
Days
Class 2
Risk

K170435 is an FDA 510(k) clearance for the NerveGuard NRFit, NerveGuard LUER. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on July 12, 2017 after a review of 149 days - within the typical 510(k) review window.

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.

View all PAJUNK GmbH Medizintechnologie devices

Submission Details

510(k) Number K170435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2017
Decision Date July 12, 2017
Days to Decision 149 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
9d slower than avg
Panel avg: 140d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

All 64
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K170435.
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
Pinpoint GT Needles
K163216 · C.R. Bard, Inc. · Jun 2017
Tuohy NRFit
K160297 · PAJUNK GmbH Medizintechnologie · Oct 2016
SPROTTE NRFit, Quincke NRFit
K160295 · PAJUNK GmbH Medizintechnologie · Oct 2016