Cleared Traditional

K850035 - EMPTY SOLUTION TRANSFER CONTAINER (FDA 510(k) Clearance)

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

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

Submission Details

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
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 128d · This submission: 151d
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 116
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