PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET— 510(k) K890095

Name: FDA 510(k) clearance K890095
Creator: U.S. Food and Drug Administration
Published: 1989-05-24

Substantially Equivalent

Kells Medical, Inc.

FDA 510(k) clearance K890095 for PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET, Substantially Equivalent on 1989-05-24. Applicant: Kells Medical, Inc.. Device class: 2.

Clearance details

Applicant: Kells Medical, Inc.
Product code: Code KPE
Device class: Class 2
Regulation: 21 CFR 880.5025
Advisory panel: General Hospital
Date received: 1989-01-10
Decision date: 1989-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redlands, CA, US

Download summary PDF View on FDA.gov ↗

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K926333 — CPR PLUS1993-11-08
K890093 — PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SET1989-07-24
K890094 — EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET1989-05-24
K861972 — DERMISTRIP1986-06-27
K844463 — DERMIDRESS1985-01-08

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.