Cleared Traditional

K141126 - UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE

K141126 is an FDA 510(k) clearance for UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE, manufactured by Unisis Corp.. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K141126 · Unisis Corp. · Anesthesiology device
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Oct 2014
Decision
183d
Days
Class 2
Risk

K141126 is an FDA 510(k) clearance for the UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Unisis Corp. (Richardson, US). The FDA issued a Cleared decision on October 31, 2014 after a review of 183 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 Unisis Corp. devices

FDA 510(k) Submission Details - K141126

510(k) Number K141126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2014
Decision Date October 31, 2014
Days to Decision 183 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 140d · This submission: 183d
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 85
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