Amia Automated PD System with Sharesource— 510(k) K151525
Substantially EquivalentDeka Research and Development
FDA 510(k) clearance K151525 for Amia Automated PD System with Sharesource, Substantially Equivalent on 2015-10-09. Applicant: Deka Research and Development. Device class: 2.
Clearance details
- Applicant
- Deka Research and Development
- Product code
- Code FKX
- Device class
- Class 2
- Regulation
- 21 CFR 876.5630
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Manchester, NH, US
Recent devices under product code FKX
view all- K250523 — Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1) +4 more
- K243371 — Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1
- K220935 — Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App
- K222318 — Fresenius Liberty Select Cycler
- K212522 — Lilliput APD System
More clearances from Deka Research and Development
view allAdverse events under product code FKX
product code FKX- Death
- 501
- Injury
- 6,720
- Malfunction
- 18,508
- Other
- 1
- Total
- 25,730
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 K151525
K-number listed on FDA's recall record- Z-0550-2024 — Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
- Z-2173-2021 — Sharesource Connectivity Platform for Use with the Amia Automated PD System
- Z-2174-2021 — Kaguya Automated Peritoneal Dialysis System
- Z-0849-2019 — AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.
- Z-0850-2019 — Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.
- Z-2597-2018 — power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500 (Japanese distribution only)
- Z-3133-2017 — Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
- Z-1565-2016 — Automated peritoneal dialysis (APD) cycler
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151525.
Data sourced from openFDA. This site is unofficial and independent of the FDA.