Cleared Traditional

K832858 - INTRADISCAL THERAPY TRAY

K832858 is the FDA 510(k) clearance for INTRADISCAL THERAPY TRAY by Ulti-Med Intl., Inc.. It is a Class 2 General Hospital device (product code FMI) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K832858 · Ulti-Med Intl., Inc. · General Hospital
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Sep 1983
Decision
37d
Days
Class 2
Risk

K832858 is an FDA 510(k) clearance for the INTRADISCAL THERAPY TRAY. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Ulti-Med Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1983 after a review of 37 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 Ulti-Med Intl., Inc. devices

Submission Details

510(k) Number K832858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1983
Decision Date September 29, 1983
Days to Decision 37 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
92d faster than avg
Panel avg: 129d · This submission: 37d
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 227
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K832858.
AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY
K842542 · American Pharmaseal Div. Ahsc · Aug 1984
OHIO HEAT REFLECTING PATCH
K840967 · Ohio Medical Products · Mar 1984
INTRADISCAL THERAPY TRAY
K834553 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1984
NEONATAL LUMBAR PUNCTURE TRAY
K832556 · American Pharmaseal Div. Ahsc · Sep 1983
INTRADISCAL THERAPY NEEDLE
K831610 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1983
VISITEC NEEDLE RANGE (GENERAL HOSPITAL)
K811966 · Visitec Co. · Jul 1981