Cleared Traditional

K243690 - SonoMSK

K243690 is an FDA 510(k) clearance for SonoMSK, manufactured by PAJUNK GmbH Medizintechnologie. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K243690 · PAJUNK GmbH Medizintechnologie · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Jul 2025
Decision
214d
Days
Class 2
Risk

K243690 is an FDA 510(k) clearance for the SonoMSK. 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 1, 2025 after a review of 214 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

FDA 510(k) Submission Details - K243690

510(k) Number K243690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2024
Decision Date July 01, 2025
Days to Decision 214 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
74d slower than avg
Panel avg: 140d · This submission: 214d
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 Peers - BSP Needle, Conduction, Anesthetic (w/wo Introducer)

All 104
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K243690.
SonoPlex STIM
K243682 · PAJUNK GmbH Medizintechnologie · Jun 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