Cleared Traditional

K790086 - NEEDLE

K790086 is the FDA 510(k) clearance for NEEDLE by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 General Hospital device (product code FMI) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K790086 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital

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Feb 1979

Decision

22d

Days

Class 2

Risk

K790086 is an FDA 510(k) clearance for the NEEDLE, TRUCARE VACUTAINER. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on February 8, 1979 after a review of 22 days - a notably fast clearance cycle.

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: 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number	K790086 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 17, 1979
Decision Date	February 08, 1979
Days to Decision	22 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

107d faster than avg

Panel avg: 129d · This submission: 22d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

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 259

Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K790086.

VISITEC NEEDLE RANGE (GENERAL HOSPITAL)

K811966 · Visitec Co. · Jul 1981

DOUBLE ENDED FILTERED TRANSFER NEEDLE

K801107 · Burron Medical Products, Inc. · May 1980

DOUBLE ENDED VENTED TRANSFER DEVICE

K801108 · Burron Medical Products, Inc. · May 1980

BLOOD GAS TRAY #4024

K771667 · Concord Laboratories, Inc. · Oct 1977

TERUFUSION BLOOD ADMIN. SET

K771209 · Terumo America, Inc. · Jul 1977

DISP. HYPODERMIC NEEDLE

K771203 · Terumo America, Inc. · Jul 1977

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K790086

Bd Becton Dickinson Vacutainer Systems Preanalytic

Washington, DC · US

Regulatory profile

632 submissions 625 cleared

99% clearance rate · Active in General Hospital

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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