Disposable Infusion Bag for Parenteral Nutrition— 510(k) K252079
Substantially EquivalentBeijing L&Z Medical Technology Development Co., Ltd.
FDA 510(k) clearance K252079 for Disposable Infusion Bag for Parenteral Nutrition, Substantially Equivalent on 2026-04-02. Applicant: Beijing L&Z Medical Technology Development Co., Ltd.. Device class: 2.
Summary
Beijing L&Z Medical Technology Development's Disposable Infusion Bag for Parenteral Nutrition is filed under product code KPE (Container, I.V.).
Class II, 21 CFR 880.5025. It came in as a Traditional 510(k), and General Hospital is both the classification panel and the review panel.
Beijing L&Z Medical Technology Development filed from Beijing, China. Review took 274 calendar days (July 2, 2025 to April 2, 2026).
Clearance details
- Applicant
- Beijing L&Z Medical Technology Development Co., Ltd.
- Product code
- Product code KPE
- Device class
- Class 2
- Regulation
- 21 CFR 880.5025
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beijing, CN
Recent devices under product code KPE
view allMore clearances from Beijing L&Z Medical Technology Development Co., Ltd.
view allAdverse events under product code KPE
product code KPE- Malfunction
- 1,000
- Other
- 1
- Total
- 1,001
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.