Citric Complete Dry Citric Acid (45X)— 510(k) K171750
Substantially EquivalentDimesol USA, LLC
FDA 510(k) clearance K171750 for Citric Complete Dry Citric Acid (45X), Substantially Equivalent on 2018-03-06. Applicant: Dimesol USA, LLC. Device class: 2.
Clearance details
- Applicant
- Dimesol USA, LLC
- Product code
- Code KPO
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lewisberry, PA, US
Recent devices under product code KPO
view allAdverse events under product code KPO
product code KPO- Death
- 14
- Malfunction
- 775
- Other
- 20
- Total
- 809
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K171750
K-number listed on FDA's recall record- Z-3135-2026 — Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25
- Z-0820-2025 — Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171750.
Data sourced from openFDA. This site is unofficial and independent of the FDA.