LIFEPORT AMBULATORY INFUSION PUMP— 510(k) K854318

Substantially Equivalent

Strato Medical Corp.

FDA 510(k) clearance K854318 for LIFEPORT AMBULATORY INFUSION PUMP, Substantially Equivalent on 1986-03-18. Applicant: Strato Medical Corp..

Clearance details

Applicant: Strato Medical Corp.
Product code: Code FRN
Advisory panel: General Hospital
Date received: 1985-10-28
Decision date: 1986-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, US

Download summary PDF View on FDA.gov ↗

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.