FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SODIUM BICARBONATE POWDER/BICARBONATE HEMODIALYSIS
K Number: K863631
·
Decision Oct 16, 1986
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
122
Applicant Total
14
Review Days
29
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Basic Information
- Device Name
- SODIUM BICARBONATE POWDER/BICARBONATE HEMODIALYSIS
- K Number
- K863631
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- American Healthcare Corp.
- Date Received
- September 17, 1986
- Decision Date
- October 16, 1986
- 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)
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)
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HemoCare Bicarbonate Concentrate Set (BCS)
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pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)
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FDA 510(k)
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Other Clearances by American Healthcare Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K924192 | I.V. START KIT (AHC-50-54954 | Aug 27, 1993 | Unknown |
| K923938 | IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER | Jun 17, 1993 | Unknown |
| K923939 | IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER | Jun 17, 1993 | Unknown |
| K923940 | IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE | Jun 17, 1993 | Unknown |
| K923941 | IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE | Jun 17, 1993 | Unknown |
| K924193 | TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685) | Jun 16, 1993 | Unknown |
| K924191 | TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL | Apr 2, 1993 | Unknown |
| K924195 | TRACHEOSTOMY CARE SET W/FORCEPS & GAUZE TRACH DRES | Jan 6, 1993 | Substantially Equivalent |
| K924194 | TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686) | Jan 6, 1993 | Unknown |
| K923834 | TRACHEOSTOMY CARE SET WITH GLOVES | Dec 10, 1992 | Unknown |