Water Pure, Inc.

FDA Regulatory Profile

Water Pure, Inc. appears in FDA public data with 1 recall, 2 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (H-0213-2026, Class II) was initiated on October 24, 2025. Its most recent 510(k) clearance was granted on October 23, 1987.

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
H-0213-2026Class IIMy Bladder; Supports normal bladder tone & control; Dietary Supplement; packaged in white HDPE bottlOctober 24, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K873487HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIESOctober 23, 1987
K863720HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIESOctober 29, 1986