Cleared Traditional

K771432 - HICALIQ IVH BAG

K771432 is the FDA 510(k) clearance for HICALIQ IVH BAG by Terumo America, Inc.. It is a Class 2 General Hospital device (product code KPE) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K771432 · Terumo America, Inc. · General Hospital
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Sep 1977
Decision
58d
Days
Class 2
Risk

K771432 is an FDA 510(k) clearance for the HICALIQ IVH BAG. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Terumo America, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 28, 1977 after a review of 58 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 Terumo America, Inc. devices

Submission Details

510(k) Number K771432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1977
Decision Date September 28, 1977
Days to Decision 58 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
71d faster than avg
Panel avg: 129d · This submission: 58d
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 38
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K771432.
TOTAL PARENTERAL NUTRITION SET BAG
K801652 · Cutter Laboratories, Inc. · Aug 1980
LIFE CARE 1000ML.EMP. CONT. W/AT. Y-TRAN
K791774 · Abbott Laboratories · Oct 1979
ADDITIVE HINGE CAP
K791796 · Abbott Laboratories · Oct 1979
LIFECARE EMPTY CONTAINER
K771228 · Abbott Laboratories · Aug 1977
ADDITIVE CAP (2B8905)
K760880 · Travenol Laboratories, S.A. · Dec 1976