Cleared Traditional

LIGHT SABER SPINAL NEEDLE (K021084) - FDA 510(k) Clearance

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

K021084 · Minrad, Inc. · Radiology device
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Jul 2002
Decision
90d
Days
Class 2
Risk

K021084 is an FDA 510(k) clearance for the LIGHT SABER SPINAL NEEDLE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Minrad, Inc. (Buffalo, US). The FDA issued a Cleared decision on July 3, 2002 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 880.5860 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Minrad, Inc. devices

Submission Details

510(k) Number K021084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2002
Decision Date July 03, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 Radiology devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 209
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K021084.
MERIT MEDICAL 1-ML SYRINGE
K024052 · Merit Medical Systems, Inc. · Feb 2003
BD INSULIN SYRINGE
K024112 · Becton, Dickinson & CO · Jan 2003
BONE GRAFT SYRINGE, MODEL 8600-00X0
K023088 · Wrightmedicaltechnologyinc · Oct 2002
PCCS GRAFT DELIVERY SYSTEM
K021071 · Biomet, Inc. · Jul 2002
DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML
K020666 · Baxter Healthcare Corp · Jun 2002
DUPLOREACH
K014088 · Baxter Healthcare Corp · Jun 2002