SMARTBLOCK PAIN PUMP— 510(k) K072053

Name: FDA 510(k) clearance K072053
Creator: U.S. Food and Drug Administration
Published: 2007-11-06

Substantially Equivalent

Medical Flow Systems, Ltd.

FDA 510(k) clearance K072053 for SMARTBLOCK PAIN PUMP, Substantially Equivalent on 2007-11-06. Applicant: Medical Flow Systems, Ltd.. Device class: 2.

Clearance details

Applicant: Medical Flow Systems, Ltd.
Product code: Code MEB
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2007-07-26
Decision date: 2007-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leawood, KS, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MEB

product code MEB

Death: 6
Injury: 160
Malfunction: 10,053
Other: 5
Total: 10,224

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.