FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RM3 RENAL PRESERVATION SYSTEM
K Number: K053169
·
Decision Jan 17, 2006
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
12
Review Days
64
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
- RM3 RENAL PRESERVATION SYSTEM
- K Number
- K053169
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5880
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Waters Instruments, Inc.
- Date Received
- November 14, 2005
- Decision Date
- January 17, 2006
- Product Code
- KDK
- 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 |
|---|---|---|---|
| KDK | Container, Transport, Kidney | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KDK), ordered by most recent decision date.
HYPOTRANS MODEL 750
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KEITHLEY LYMPHOCYTE DEPLETION CART
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Waters Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K042224 | RM3 RENAL PRESERVATION SYSTEM | Oct 22, 2004 | Substantially Equivalent |
| K971571 | RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT | Jul 29, 1997 | Substantially Equivalent |
| K921519 | OXICOM-2100 | Oct 23, 1992 | Substantially Equivalent |
| K911207 | OXICOMPLUS | Aug 26, 1991 | Substantially Equivalent |
| K863210 | VELCOM-100 | Nov 26, 1986 | Substantially Equivalent |
| K862161 | OSC-80 OXIMETER | Aug 18, 1986 | Substantially Equivalent |
| K852909 | MVP - 6000 | Nov 14, 1985 | Substantially Equivalent |
| K834408 | TX-2 THERMAL DILUTION CARDIAC OUTPUT | Aug 23, 1984 | Substantially Equivalent |
| K841876 | POLYURETHANE THERMAL DILUTION CATHET | Jul 13, 1984 | Substantially Equivalent |
| K813585 | WATERS ILEOSTOMY VALVE | Apr 9, 1982 | Substantially Equivalent |