Company ยท US
Isopure Corp
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2020. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 22, 2020 | K191093 | Isopure Dry Acid Dissolution System Isopure, Corp. | KPO |
| Mar 29, 2012 | K120005 | ACDS Isopure, Corp. | KPO |
| Jan 26, 2012 | K112427 | BICARB MIXING AND DISTRIBUTION SYSTEM Isopure, Corp. | FIN |
| Oct 7, 2004 | K041163 | ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES Isopure, Corp. | FIP |
| Jan 24, 2000 | K993200 | MD 420/440/460/470/480/490 Isopure, Corp. | FIP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 13, 2022 | Isopure Corp Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in
Hemodialysis facilities for the storage and Terminated |
KPO | K120005 |
| Apr 28, 2022 | Isopure Corp Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) Open, Classified |
FIN | K112427 |
| Jan 19, 2020 | Isopure Corp Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part) Terminated |
N/A | None listed |
| Jan 19, 2020 | Isopure Corp Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3 Terminated |
FIN | K112427 |
| Jan 19, 2020 | Isopure Corp Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3 Terminated |
KPO | K120005 |
| Nov 16, 2011 | Isopure Corp Step 2, 3000-22000 GPD (Sodium Hydroxide 2.0N) cleaning solution. 4 oz plastic bottle. Lot # 11IC002, Serial #'s: 11IC00210 - 11IC002294.
The Step 2, 3000-2000 GPD chemical is used in the cleaning Terminated |
KPO | K041163 |
| Oct 11, 2011 | Isopure Corp Sodium Bicarbonate Mixing and Delivery System Software v 7.1. Model # MD-380, Serial Numbers: 5103031102, 5101101101, 5102161007, 5103221007, 5104221007, 5105101008, 5109131010, 5111231011, 5114301012 Terminated |
FJP | K993272 |