Cleared Traditional

DiscCath Needle Set (K212328) - FDA 510(k) Clearance

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

K212328 · Disccath, LLC · Anesthesiology device
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Sep 2021
Decision
61d
Days
Class 2
Risk

K212328 is an FDA 510(k) clearance for the DiscCath Needle Set. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Disccath, LLC (New York, US). The FDA issued a Cleared decision on September 26, 2021 after a review of 61 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Disccath, LLC devices

Submission Details

510(k) Number K212328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2021
Decision Date September 26, 2021
Days to Decision 61 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
79d faster than avg
Panel avg: 140d · This submission: 61d
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 43
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K212328.
BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle
K211085 · Becton, Dickinson and Company · Jul 2022
BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle
K210978 · Becton, Dickinson and Company · Dec 2021
RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles
K203668 · Myco Medical Supplies, Inc. · Sep 2021
BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle
K193131 · Becton, Dickinson and Company · Sep 2020
Stimuplex Onvision System
K192914 · Philips Medical Systems Nederland B.V. · May 2020
Ancora Nerve Block Catheter Set
K191290 · Ancora Medical Technology · Feb 2020