HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES— 510(k) K873487

Name: FDA 510(k) clearance K873487
Creator: U.S. Food and Drug Administration
Published: 1987-10-23

Substantially Equivalent

Water Pure, Inc.

FDA 510(k) clearance K873487 for HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES, Substantially Equivalent on 1987-10-23. Applicant: Water Pure, Inc.. Device class: 2.

Clearance details

Applicant: Water Pure, Inc.
Product code: Code FIP
Device class: Class 2
Regulation: 21 CFR 876.5665
Advisory panel: Gastroenterology, Urology
Date received: 1987-08-31
Decision date: 1987-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, KY, US

Download summary PDF View on FDA.gov ↗

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K863720 — HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES1986-10-29

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.