Cleared Traditional

IMD's Lumbar Puncture Needle (K170112) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170112 · International Medical Development, Inc.(Imd) · Anesthesiology device
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Feb 2018
Decision
386d
Days
Class 2
Risk

K170112 is an FDA 510(k) clearance for the IMD's Lumbar Puncture Needle. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by International Medical Development, Inc.(Imd) (Huntsville, US). The FDA issued a Cleared decision on February 2, 2018 after a review of 386 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 International Medical Development, Inc.(Imd) devices

Submission Details

510(k) Number K170112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2017
Decision Date February 02, 2018
Days to Decision 386 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
246d slower than avg
Panel avg: 140d · This submission: 386d
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 Consultant

J.E. Lincoln and Associates
John E. Lincoln

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 43
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K170112.
Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters
K172410 · Smiths Medical Asd, Inc. · Jun 2018
GRAFTSITE
K173110 · Summit Medical , Ltd. · May 2018
StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle
K173321 · Teleflex Medical · Apr 2018
EchoGlo Needle
K171968 · Smiths Medical Asd, Inc. · Jan 2018
Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles
K171518 · Zhejiang Kindly Medical Devices Co., Ltd. · Jan 2018
Pinpoint GT Needles
K163216 · C.R. Bard, Inc. · Jun 2017