Cleared Traditional

K901810 - MICRO-SP LUMBAR PUNCTURE (SPINAL) NEEDLE

K901810 is the FDA 510(k) clearance for MICRO-SP LUMBAR PUNCTURE (SPINAL) NEEDLE by Neuro Technology. It is a Class 2 Anesthesiology device (product code BSP) cleared through the Traditional 510(k) pathway after a 405-day FDA review.

K901810 · Neuro Technology · Anesthesiology device
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May 1991
Decision
405d
Days
Class 2
Risk

K901810 is an FDA 510(k) clearance for the MICRO-SP LUMBAR PUNCTURE (SPINAL) NEEDLE. 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 30, 1991 after a review of 405 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

Submission Details

510(k) Number K901810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1990
Decision Date May 30, 1991
Days to Decision 405 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
265d slower than avg
Panel avg: 140d · This submission: 405d
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 K901810.
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