EMPTY ADMIXTURE CONTAINERS— 510(k) K771121

Name: FDA 510(k) clearance K771121
Creator: U.S. Food and Drug Administration
Published: 1977-08-03

Substantially Equivalent

Medi, Inc.

FDA 510(k) clearance K771121 for EMPTY ADMIXTURE CONTAINERS, Substantially Equivalent on 1977-08-03. Applicant: Medi, Inc.. Device class: 2.

Clearance details

Applicant: Medi, Inc.
Product code: Code KPE
Device class: Class 2
Regulation: 21 CFR 880.5025
Advisory panel: General Hospital
Date received: 1977-06-22
Decision date: 1977-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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 Medi, Inc.

view all

K770141 — INSPIROMETER RESPIRATORY EXERCISER1977-02-01

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.