Cleared Traditional

K241953 - SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology (FDA 510(k) Clearance)

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

K241953 · PAJUNK GmbH Medizintechnologie · Anesthesiology device
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Nov 2024
Decision
142d
Days
Class 2
Risk

K241953 is an FDA 510(k) clearance for the SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology. 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 November 22, 2024 after a review of 142 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 K241953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2024
Decision Date November 22, 2024
Days to Decision 142 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
3d slower than avg
Panel avg: 139d · This submission: 142d
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
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