Cleared Traditional

TUF TRACK MODEL TT83 CUBICLE TRACK & IV83 INTR TRK (K852938) - FDA 510(k) Clearance

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

K852938 · Northern Customfab, Inc. · General Hospital
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Sep 1985
Decision
82d
Days
Class 2
Risk

K852938 is an FDA 510(k) clearance for the TUF TRACK MODEL TT83 CUBICLE TRACK & IV83 INTR TRK. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Northern Customfab, Inc. (North Bay,Ont Plb 8k4 Ca, CA). The FDA issued a Cleared decision on September 30, 1985 after a review of 82 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5025 - 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 Northern Customfab, Inc. devices

Submission Details

510(k) Number K852938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1985
Decision Date September 30, 1985
Days to Decision 82 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
47d faster than avg
Panel avg: 129d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPE Container, I.v.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5025
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 - KPE Container, I.v.

All 30
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K852938.
EMPTY VIAFLEX PLASTIC CONTAINER
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K883400 · Abbott Laboratories · Dec 1989
NUTRIMIX EMPTY CONTAINER
K860042 · Abbott Laboratories · Apr 1986
NUTRIMIX EMPTY CONTAINER
K844077 · Abbott Laboratories · Feb 1985
LIFE CARE 1000ML.EMP. CONT. W/AT. Y-TRAN
K791774 · Abbott Laboratories · Oct 1979
ADDITIVE HINGE CAP
K791796 · Abbott Laboratories · Oct 1979