Cleared Traditional

K911221 - ATRAUMATIC SPECIAL SPROTTE NEEDLE

K911221 is an FDA 510(k) clearance for ATRAUMATIC SPECIAL SPROTTE NEEDLE, manufactured by Pajunk GmbH. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 493-day FDA review.

K911221 · Pajunk GmbH · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
493d
Days
Class 2
Risk

K911221 is an FDA 510(k) clearance for the ATRAUMATIC SPECIAL 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 July 24, 1992 after a review of 493 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Pajunk GmbH devices

FDA 510(k) Submission Details - K911221

510(k) Number K911221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1991
Decision Date July 24, 1992
Days to Decision 493 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
353d slower than avg
Panel avg: 140d · This submission: 493d
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 78
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K911221.
PAJUNK STANDARD SPROTTE NEEDLE W/ INTRODUCER CANN.
K923003 · Rusch, Inc. · Apr 1993
PHARMASEAL CLEAR HUB SPINAL NEEDLE
K920305 · Baxter Healthcare Corp · Jan 1993
CURITY CALIBRATED TUOHY TYPE EPIDURAL NEEDLE
K921288 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jan 1993
SPINAL TAP NEEDLE
K910652 · Gesco Intl., Inc. · Jul 1991
CURITY(R) CALIB TUOHY TYPE EPIDUR NEEDLE FIX WING
K910791 · Kendall Healthcare Products Co. Div.Of Tyco Health · May 1991
SPINAL NEEDLE
K895453 · Advance Medical Designs, Inc. · Oct 1989