Cleared Traditional

K982541 - VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608

K982541 is an FDA 510(k) clearance for VACUTAINER BRAND ECLIPSE BLOOD COLLECTI..., manufactured by Becton Dickinson Vacutainer Systems. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K982541 · Becton Dickinson Vacutainer Systems · General Hospital
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Oct 1998
Decision
99d
Days
Class 2
Risk

K982541 is an FDA 510(k) clearance for the VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Becton Dickinson Vacutainer Systems (Franklin Lake, US). The FDA issued a Cleared decision on October 28, 1998 after a review of 99 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Becton Dickinson Vacutainer Systems devices

FDA 510(k) Submission Details - K982541

510(k) Number K982541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1998
Decision Date October 28, 1998
Days to Decision 99 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 129d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 455
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K982541.
DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER
K983750 · Deroyal Industries, Inc. · Nov 1998
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FINE-JECT
K983067 · Henke Sass Wolf of America, Inc. · Oct 1998
BLUNT SYRINGE CANNULA
K971924 · B.Braun Medical, Inc. · Sep 1998
DISETRONIC PENFINE INJECTION PEN NEEDLE
K982399 · Disetronic Medical Systems · Aug 1998
FLOW-EZE BLUNT CANNULA (1999BC)
K972538 · Acacia, Inc. · Jul 1998