Cleared Traditional

K252079 - Disposable Infusion Bag for Parenteral Nutrition (FDA 510(k) Clearance)

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

K252079 · Beijing L&Z Medical Technology Development Co., Ltd. · General Hospital
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Apr 2026
Decision
274d
Days
Class 2
Risk

K252079 is an FDA 510(k) clearance for the Disposable Infusion Bag for Parenteral Nutrition. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Beijing L&Z Medical Technology Development Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on April 2, 2026 after a review of 274 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 Beijing L&Z Medical Technology Development Co., Ltd. devices

Submission Details

510(k) Number K252079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2025
Decision Date April 02, 2026
Days to Decision 274 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 128d · This submission: 274d
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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