Cleared Traditional

K982018 - LIGHT SABER ASPIRATION NEEDLE

K982018 is an FDA 510(k) clearance for LIGHT SABER ASPIRATION NEEDLE, manufactured by Minrad, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K982018 · Minrad, Inc. · General Hospital
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Aug 1998
Decision
60d
Days
Class 2
Risk

K982018 is an FDA 510(k) clearance for the LIGHT SABER ASPIRATION NEEDLE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Minrad, Inc. (Orchard Park, US). The FDA issued a Cleared decision on August 7, 1998 after a review of 60 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital 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 Minrad, Inc. devices

FDA 510(k) Submission Details - K982018

510(k) Number K982018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1998
Decision Date August 07, 1998
Days to Decision 60 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 129d · This submission: 60d
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 General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 534
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K982018.
DISETRONIC PEN
K982966 · Disetronic Medical Systems · Oct 1998
PENETREASE
K980078 · P.T. Panca Pusaka Deli · Oct 1998
HUMAPEN AND HUMAPEN ERGO
K982842 · Eli Lilly and Co. · Sep 1998
STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)
K972728 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1998
BECTON DICKINSON SYRINGES
K980580 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1998
MINRAD DRTS LIGHT SABER SYRINGE
K981140 · Minrad, Inc. · Jun 1998