MASTER MEDICAL DEVICE IS I.V. STAT 2— 510(k) K871753

Substantially Equivalent

The Master Medical Corp.

FDA 510(k) clearance K871753 for MASTER MEDICAL DEVICE IS I.V. STAT 2, Substantially Equivalent on 1987-06-05. Applicant: The Master Medical Corp..

Clearance details

Applicant: The Master Medical Corp.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 1987-05-05
Decision date: 1987-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.