Cleared Traditional

K801652 - TOTAL PARENTERAL NUTRITION SET BAG

K801652 is an FDA 510(k) clearance for TOTAL PARENTERAL NUTRITION SET BAG, manufactured by Cutter Laboratories, Inc.. The device is a Class 2 General Hospital device with product code KPE cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K801652 · Cutter Laboratories, Inc. · General Hospital
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Aug 1980
Decision
40d
Days
Class 2
Risk

K801652 is an FDA 510(k) clearance for the TOTAL PARENTERAL NUTRITION SET BAG. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Cutter Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 27, 1980 after a review of 40 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 Cutter Laboratories, Inc. devices

FDA 510(k) Submission Details - K801652

510(k) Number K801652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1980
Decision Date August 27, 1980
Days to Decision 40 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
89d faster than avg
Panel avg: 129d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPE Device Classification - Class 2, Special Controls

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 42
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K801652.
EMPTY SOLUTION TRANSFER CONTAINER
K842170 · The Healthcare Group Laboratories, Inc. · Oct 1984
CAT 3040
K830193 · Burron Medical Products, Inc. · Mar 1983
SOLUTION TRANSFER CONTAINER
K830299 · The Healthcare Group Laboratories, Inc. · Feb 1983
LIFE CARE 1000ML.EMP. CONT. W/AT. Y-TRAN
K791774 · Abbott Laboratories · Oct 1979
ADDITIVE HINGE CAP
K791796 · Abbott Laboratories · Oct 1979
HICALIQ IVH BAG
K771432 · Terumo America, Inc. · Sep 1977