FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FRESENIUS DRY ACID DISSOLUTION UNITS
K Number: K131611
·
Decision Aug 29, 2013
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
122
Applicant Total
42
Review Days
87
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Basic Information
- Device Name
- FRESENIUS DRY ACID DISSOLUTION UNITS
- K Number
- K131611
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fresenius Medical Care North America
- Date Received
- June 3, 2013
- Decision Date
- August 29, 2013
- 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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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)
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FDA Class 2
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FDA 510(k)
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pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)
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Other Clearances by Fresenius Medical Care North America
| K Number | Device Name | ||
|---|---|---|---|
| K252181 | AquaA | Sep 9, 2025 | Substantially Equivalent |
| K162488 | Optiflux dialyzer | Apr 6, 2017 | Substantially Equivalent |
| K152953 | CRIT-LINE CLIP (CLIC) BLOOD CHAMBER | Nov 5, 2015 | Substantially Equivalent |
| K152367 | Optiflux dialyzer | Oct 29, 2015 | Substantially Equivalent |
| K123262 | OPTIFLUX ULTRA DIALYZER | Jan 6, 2014 | Substantially Equivalent |
| K124035 | 2008K@HOME HEMODIALYSIS MACHINE | Jul 3, 2013 | Substantially Equivalent |
| K121341 | FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM | Dec 6, 2012 | Substantially Equivalent |
| K120017 | FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM | Feb 2, 2012 | Substantially Equivalent |
| K113427 | FRESENIUS 2008T HEMODIALYSIS MACHINE | Dec 21, 2011 | Substantially Equivalent |
| K070049 | FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR | Feb 3, 2011 | Substantially Equivalent |