Cleared Traditional

K831610 - INTRADISCAL THERAPY NEEDLE

K831610 is an FDA 510(k) clearance for INTRADISCAL THERAPY NEEDLE, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K831610 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
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Jul 1983
Decision
54d
Days
Class 2
Risk

K831610 is an FDA 510(k) clearance for the INTRADISCAL THERAPY NEEDLE. 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 July 12, 1983 after a review of 54 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

FDA 510(k) Submission Details - K831610

510(k) Number K831610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1983
Decision Date July 12, 1983
Days to Decision 54 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
75d faster than avg
Panel avg: 129d · This submission: 54d
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 494
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K831610.
INTRADISCAL THERAPY TRAY
K832858 · Ulti-Med Intl., Inc. · Sep 1983
NEONATAL LUMBAR PUNCTURE TRAY
K832556 · American Pharmaseal Div. Ahsc · Sep 1983
AVL 0073 MICROSAMPLER
K831395 · Avl Scientific Corp. · Jul 1983
INFANT CARE SYSTEM
K823899 · Narco Scientific · Apr 1983
NON-STERILE REUSABLE NEEDLES
K823255 · Vertex Medical Corp. · Nov 1982
HYPOSERMIC NEEDLES
K813545 · Optical Micro Systems, Inc. · Jan 1982