Cleared Traditional

K850035 - EMPTY SOLUTION TRANSFER CONTAINER

K850035 is an FDA 510(k) clearance for EMPTY SOLUTION TRANSFER CONTAINER, manufactured by The Healthcare Group Laboratories, Inc.. The device is a Class 2 General Hospital device with product code KPE cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K850035 · The Healthcare Group Laboratories, Inc. · General Hospital
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Jun 1985
Decision
151d
Days
Class 2
Risk

K850035 is an FDA 510(k) clearance for the EMPTY SOLUTION TRANSFER CONTAINER. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by The Healthcare Group Laboratories, Inc. (Orem, US). The FDA issued a Cleared decision on June 7, 1985 after a review of 151 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 The Healthcare Group Laboratories, Inc. devices

FDA 510(k) Submission Details - K850035

510(k) Number K850035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1985
Decision Date June 07, 1985
Days to Decision 151 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
22d slower than avg
Panel avg: 129d · This submission: 151d
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 43
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K850035.
VIAL DECANTER
K852893 · Advance Medical Designs, Inc. · Sep 1985
BAG DECANTER
K852777 · Advance Medical Designs, Inc. · Aug 1985
BOTTLE DECANTER
K852778 · Advance Medical Designs, Inc. · Aug 1985
NUTRIMIX EMPTY CONTAINER
K844077 · Abbott Laboratories · Feb 1985
EMPTY SOLUTION TRANSFER CONTAINER
K842170 · The Healthcare Group Laboratories, Inc. · Oct 1984
CAT 3040
K830193 · Burron Medical Products, Inc. · Mar 1983