UPT Series Medical RO Water System— 510(k) K151637

Substantially Equivalent

Specialty Water Technologies

FDA 510(k) clearance K151637 for UPT Series Medical RO Water System, Substantially Equivalent on 2015-09-23. Applicant: Specialty Water Technologies.

Clearance details

Applicant: Specialty Water Technologies
Product code: Code FIP
Advisory panel: Gastroenterology, Urology
Date received: 2015-06-17
Decision date: 2015-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlinda, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FIP

product code FIP

Malfunction: 490
Total: 490

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.