SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL— 510(k) K201936

Name: FDA 510(k) clearance K201936
Creator: U.S. Food and Drug Administration
Published: 2021-05-06

Substantially Equivalent

Gilero, LLC

FDA 510(k) clearance K201936 for SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL, Substantially Equivalent on 2021-05-06. Applicant: Gilero, LLC. Device class: 2.

Clearance details

Applicant: Gilero, LLC
Product code: Code KPE
Device class: Class 2
Regulation: 21 CFR 880.5025
Advisory panel: General Hospital
Date received: 2020-07-13
Decision date: 2021-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morrisville, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPE

view all

K252079 — Disposable Infusion Bag for Parenteral Nutrition2026-04-02
K251980 — ClaveQS Bag2026-03-20
K251139 — KabiHelp® Uno; KabiHelp® Advance plus2026-01-09
K252094 — eZSURE Empty Fluid Container2025-08-01
K250459 — DMRX 100ml Empty Container Solution +3 more2025-04-18

More clearances from Gilero, LLC

view all

K230718 — UTC 3mL Medication Cartridge2023-06-15

Adverse events under product code KPE

product code KPE

Malfunction: 1,000
Other: 1
Total: 1,001

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.