FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NATURALYTE BICARBONATE DIALYSATE 4400
K Number: K823115
·
Decision Dec 3, 1982
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
85
Applicant Total
43
Review Days
43
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- NATURALYTE BICARBONATE DIALYSATE 4400
- K Number
- K823115
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3510
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Erika, Inc.
- Date Received
- October 21, 1982
- Decision Date
- December 3, 1982
- Product Code
- KRO
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KRO), ordered by most recent decision date.
Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper
FDA 510(k)
FDA Class 2
·Orthopedic
Stem Extension Line (USTAR II System)
FDA 510(k)
FDA Class 2
·Orthopedic
Triathlon® Hinge Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
ATTUNE Revision Hinge Knee
FDA 510(k)
FDA Class 2
·Orthopedic
EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse
FDA 510(k)
FDA Class 2
·Orthopedic
ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Erika, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K853134 | NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8 | Nov 6, 1985 | Substantially Equivalent |
| K852310 | NATURALYTE BICARBONATE CONCENTRATE-DRY PACK | Jul 26, 1985 | Substantially Equivalent |
| K852309 | ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1 | Jul 26, 1985 | Substantially Equivalent |
| K850865 | TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1- | Apr 3, 1985 | Substantially Equivalent |
| K850866 | TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L | Apr 3, 1985 | Substantially Equivalent |
| K850655 | TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2 | Mar 7, 1985 | Substantially Equivalent |
| K850654 | TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID | Mar 7, 1985 | Substantially Equivalent |
| K842436 | ERIKA NEGATIVE PRESS. ARTERIAL BLOOD | Jul 13, 1984 | Substantially Equivalent |
| K831175 | FILTRYZER HOLLOW FIBER ARTIF. KIDNEY | Jun 22, 1984 | Substantially Equivalent |
| K831173 | TORAY INDUSTRIES FILTRYZER HOLLOW FIBER | Jun 22, 1984 | Substantially Equivalent |