Cleared Traditional

K782113 - CAP, TAMPER PROOF PLASTIC

K782113 is an FDA 510(k) clearance for CAP, manufactured by Acacia, Inc.. The device is a Class 2 General Hospital device with product code KPE cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K782113 · Acacia, Inc. · General Hospital
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Jun 1979
Decision
164d
Days
Class 2
Risk

K782113 is an FDA 510(k) clearance for the CAP, TAMPER PROOF PLASTIC. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Acacia, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 1, 1979 after a review of 164 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Acacia, Inc. devices

FDA 510(k) Submission Details - K782113

510(k) Number K782113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1978
Decision Date June 01, 1979
Days to Decision 164 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
35d slower than avg
Panel avg: 129d · This submission: 164d
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 55
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K782113.
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
HICALIQ IVH BAG
K771432 · Terumo America, Inc. · Sep 1977
LIFECARE EMPTY CONTAINER
K771228 · Abbott Laboratories · Aug 1977
ADDITIVE CAP (2B8905)
K760880 · Travenol Laboratories, S.A. · Dec 1976