Cleared Traditional

INTRAVENOUS NEEDLE (K832904) - FDA 510(k) Clearance

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

K832904 · Yolan R. Guttman · General Hospital
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Mar 1984
Decision
214d
Days
Class 2
Risk

K832904 is an FDA 510(k) clearance for the INTRAVENOUS NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Yolan R. Guttman (Mchenry, US). The FDA issued a Cleared decision on March 30, 1984 after a review of 214 days - an extended review 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: 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 Yolan R. Guttman devices

Submission Details

510(k) Number K832904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1983
Decision Date March 30, 1984
Days to Decision 214 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 129d · This submission: 214d
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 197
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K832904.
MONOJECT STERILE M400 PLASTIC&STERILE M401 ALUMINU
K854549 · Sherwood Medical Co. · Feb 1986
VASCULAR IMPLANT ACCESS NEEDLE SET
K851103 · Baxter Healthcare Corp · Jul 1985
MONOJECT MENGHINI SOFT TISSUE BIOPSY
K843264 · Sherwood Medical Co. · Dec 1984
INTRADISCAL THERAPY TRAY
K834553 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1984
INTRADISCAL THERAPY NEEDLE
K831610 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1983
NEEDLE, TRUCARE VACUTAINER
K790086 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1979