Cleared Traditional

K243682 - SonoPlex STIM (FDA 510(k) Clearance)

Also includes:
SonoPlex II

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243682 · PAJUNK GmbH Medizintechnologie · Anesthesiology device
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Jun 2025
Decision
210d
Days
Class 2
Risk

K243682 is an FDA 510(k) clearance for the SonoPlex STIM. 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 June 27, 2025 after a review of 210 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.

View all PAJUNK GmbH Medizintechnologie devices

Submission Details

510(k) Number K243682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2024
Decision Date June 27, 2025
Days to Decision 210 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
71d slower than avg
Panel avg: 139d · This submission: 210d
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 151
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K243682.
SonoMSK
K243690 · PAJUNK GmbH Medizintechnologie · Jul 2025
SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture
K250774 · PAJUNK GmbH Medizintechnologie · Jun 2025
SonoTAP and SonoTAP II
K243525 · PAJUNK GmbH Medizintechnologie · Mar 2025
SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology
K241953 · PAJUNK GmbH Medizintechnologie · Nov 2024
SonoBlock
K241954 · PAJUNK GmbH Medizintechnologie · Sep 2024
Reach Needle
K240253 · Aerin Medical, Inc. · Mar 2024