Cleared Traditional

ATRAUMATIC STANDARD SPROTTE NEEDLE (K911260) - FDA 510(k) Clearance

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

K911260 · Pajunk GmbH · Anesthesiology device
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Oct 1991
Decision
213d
Days
Class 2
Risk

K911260 is an FDA 510(k) clearance for the ATRAUMATIC STANDARD SPROTTE NEEDLE. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Pajunk GmbH (Washington, US). The FDA issued a Cleared decision on October 21, 1991 after a review of 213 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 devices

Submission Details

510(k) Number K911260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1991
Decision Date October 21, 1991
Days to Decision 213 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 140d · This submission: 213d
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 44
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K911260.
MONOJECT TUOHY POINT EPIDURAL NEEDLE (22G X 3 1/2)
K951411 · Sherwood Medical Co. · May 1995
MONOJECT DIAMOND POINT SPINAL NEEDLE (28G X 3 1/2)
K951265 · Sherwood Medical Co. · Apr 1995
PHARMASEAL CLEAR HUB SPINAL NEEDLE
K920305 · Baxter Healthcare Corp · Jan 1993
TSK STERIJECT STERILE EPIDURAL NEEDLE
K854149 · Pharmacia, Inc. · Oct 1985
EPINEED EPIDURAL NEEDLE
K832233 · Terumo Medical Corp. · Aug 1983
MONOJECT PLASTIC HUB SPINAL NEEDLE
K822630 · Sherwood Medical Co. · Oct 1982