Cleared Traditional

K241954 - SonoBlock (FDA 510(k) Clearance)

Also includes:
SonoBlock II

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

K241954 · PAJUNK GmbH Medizintechnologie · Anesthesiology device
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Sep 2024
Decision
70d
Days
Class 2
Risk

K241954 is an FDA 510(k) clearance for the SonoBlock. 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 September 11, 2024 after a review of 70 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 PAJUNK GmbH Medizintechnologie devices

Submission Details

510(k) Number K241954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2024
Decision Date September 11, 2024
Days to Decision 70 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
69d faster than avg
Panel avg: 139d · This submission: 70d
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 K241954.
SonoMSK
K243690 · PAJUNK GmbH Medizintechnologie · Jul 2025
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
Reach Needle
K240253 · Aerin Medical, Inc. · Mar 2024