Cleared Traditional

K831964 - CMS 2000 SERIES TPN KITS

K831964 is an FDA 510(k) clearance for CMS 2000 SERIES TPN KITS, manufactured by Currie Medical Specialties, Inc.. The device is a Class 1 General Hospital device with product code FMC cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K831964 · Currie Medical Specialties, Inc. · General Hospital
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Aug 1983
Decision
55d
Days
Class 1
Risk

K831964 is an FDA 510(k) clearance for the CMS 2000 SERIES TPN KITS. Classified as Patient Examination Glove (product code FMC), Class I - General Controls.

Submitted by Currie Medical Specialties, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 11, 1983 after a review of 55 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - 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.

FDA 510(k) Submission Details - K831964

510(k) Number K831964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1983
Decision Date August 11, 1983
Days to Decision 55 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
74d faster than avg
Panel avg: 129d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

FMC Device Classification - Class 1, General Controls

Product Code FMC Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FMC Patient Examination Glove

All 33
Devices cleared under the same product code (FMC) and FDA review panel - the closest regulatory comparables to K831964.
LATEX EXAM GLOVES, NON-STERILE
K882583 · B Und J Instruments · Jul 1988
TPN/CVP DRESSING CHANGE KIT
K840620 · Marwood Medical, Inc. · May 1984
P.T.I. DRESSING CHANGE TRAYS
K833758 · Packaging Technologies, Inc. · Jan 1984
ORTHOPEDIC SURGICAL GLOVE
K831564 · Ansell, Inc. · Jul 1983
STERILE PATIENT EXAM. GLOVES
K821043 · Phoenix Glove Co. · May 1982
FINGER COTS
K821028 · Abco Dealers, Inc. · Apr 1982
K831964 · CMS 2000 SERIES TPN KITS
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