WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS— 510(k) K991275

Name: FDA 510(k) clearance K991275
Creator: U.S. Food and Drug Administration
Published: 1999-07-01

Substantially Equivalent

Mckinley, Inc.

FDA 510(k) clearance K991275 for WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS, Substantially Equivalent on 1999-07-01. Applicant: Mckinley, Inc.. Device class: 2.

Clearance details

Applicant: Mckinley, Inc.
Product code: Code FRN
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 1999-04-14
Decision date: 1999-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheat Ridge, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FRN

view all

More clearances from Mckinley, Inc.

view all

K042228 — BEELINE MOTIV, PROPOLIS, PCA2004-11-08
K033039 — MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS2003-10-07
K032642 — BEELINE SYSTEM2003-09-23
K990461 — MCKINLEY SP DISPOSABLE INFUSION PUMP1999-06-30
K982256 — OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP1998-09-30

Adverse events under product code FRN

product code FRN

Death: 540
Injury: 6,178
Malfunction: 1,464,165
Other: 52
Total: 1,470,935

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.