Cleared Traditional

K142553 - UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle

K142553 is an FDA 510(k) clearance for UNIEVER Disposable Epidural Anesthesia ..., 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 126-day FDA review.

K142553 · Unisis Corp. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
126d
Days
Class 2
Risk

K142553 is an FDA 510(k) clearance for the UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Block.... Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Unisis Corp. (Koshigaya-Shi, JP). The FDA issued a Cleared decision on January 14, 2015 after a review of 126 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K142553

510(k) Number K142553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2014
Decision Date January 14, 2015
Days to Decision 126 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 140d · This submission: 126d
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 Consultant

Ken Block Consulting
Diane Rutherford

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K142553.
SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle
K151069 · Spectra Medical Devices, Inc. · Feb 2016
Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit
K151072 · Solo-Dex, Inc. · Jan 2016
Remington Medical Inc. Tuohy Epidural Needles
K150266 · Remington Medical, Inc. · Jun 2015
UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE
K141126 · Unisis Corp. · Oct 2014
PERICAN ULTRA
K133632 · B.Braun Medical, Inc. · Jun 2014
ANESTHESIA CONDUCTION NEEDLES
K131006 · Lccs Products Limited · Dec 2013