FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NXSTAGE PUREFLOW SOLUTION
K Number: K033386
·
Decision Nov 26, 2003
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
122
Applicant Total
51
Review Days
34
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Basic Information
- Device Name
- NXSTAGE PUREFLOW SOLUTION
- K Number
- K033386
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nxstage Medical, Inc.
- Date Received
- October 23, 2003
- Decision Date
- November 26, 2003
- Product Code
- KPO
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPO), ordered by most recent decision date.
NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)
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FDA Class 2
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Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HemoCare Bicarbonate Concentrate Set (BCS)
FDA 510(k)
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pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NxStage PureFlow Solution
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Nxstage Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232803 | NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) | Mar 14, 2024 | Substantially Equivalent |
| K233213 | NxStage PureFlow Solution | Jan 18, 2024 | Substantially Equivalent |
| K230632 | VersiHD with GuideMe software | Aug 11, 2023 | Substantially Equivalent |
| K183158 | NxStage Cartridge Express with Speedswap | Aug 9, 2019 | Substantially Equivalent |
| K181991 | NxStage Connected Health System | Sep 26, 2018 | Substantially Equivalent |
| K171331 | NxStage System One | Aug 24, 2017 | Substantially Equivalent |
| K170469 | NxStage System One Plus | May 9, 2017 | Substantially Equivalent |
| K150472 | NxStage System One | Jun 4, 2015 | Substantially Equivalent |
| K143313 | NxStage Therapeutic Plasma Exchange (TPE) Cartridge | Mar 20, 2015 | Substantially Equivalent |
| K141752 | NXSTAGE SYSTEM ONE | Dec 19, 2014 | Substantially Equivalent |