Cleared Traditional

K901811 - ADD'L DATA E-SP MULTIPURPOSE EPIDURAL SPINALNEEDLE

K901811 is an FDA 510(k) clearance for ADD'L DATA E-SP MULTIPURPOSE EPIDURAL S..., manufactured by Neuro Technology. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 403-day FDA review.

K901811 · Neuro Technology · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1991
Decision
403d
Days
Class 2
Risk

K901811 is an FDA 510(k) clearance for the ADD'L DATA E-SP MULTIPURPOSE EPIDURAL SPINALNEEDLE. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Neuro Technology (Tempe, US). The FDA issued a Cleared decision on May 28, 1991 after a review of 403 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 Neuro Technology devices

FDA 510(k) Submission Details - K901811

510(k) Number K901811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1990
Decision Date May 28, 1991
Days to Decision 403 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
263d slower than avg
Panel avg: 140d · This submission: 403d
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 129
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K901811.
ATRAUMATIC STANDARD SPROTTE NEEDLE
K911202 · Pajunk GmbH · May 1992
ATRAUMATIC STANDARD SPROTTE NEEDLE
K911260 · Pajunk GmbH · Oct 1991
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
TSK STERIJECT STERILE EPIDURAL NEEDLE
K854149 · Pharmacia, Inc. · Oct 1985