Cleared Traditional

K021084 - LIGHT SABER SPINAL NEEDLE

K021084 is an FDA 510(k) clearance for LIGHT SABER SPINAL NEEDLE, manufactured by Minrad, Inc.. The device is a Class 2 Radiology device with product code FMF cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K021084

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.

FMF Device Classification - Class 2, Special Controls

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 316
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K021084.
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K023271 · Terumo Medical Corp. · Dec 2002
BONE GRAFT SYRINGE, MODEL 8600-00X0
K023088 · Wrightmedicaltechnologyinc · Oct 2002
MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM
K022246 · Depuyacromed · Aug 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