FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG
K Number: K911106
·
Decision May 28, 1991
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
181
Applicant Total
505
Review Days
77
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
- MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG
- K Number
- K911106
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Baxter Healthcare Corp
- Date Received
- March 12, 1991
- Decision Date
- May 28, 1991
- Product Code
- KOC
- 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 |
|---|---|---|---|
| KOC | Accessories, Blood Circuit, Hemodialysis | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KOC), ordered by most recent decision date.
BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Blood Tubing Lines for Hemodialysis AV06C-E
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CAREline Airless Hemodialysis Blood Tubing Sets
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Baxter Healthcare Corp
| K Number | Device Name | ||
|---|---|---|---|
| K190910 | PrisMax System Version 2 | Jul 25, 2019 | Substantially Equivalent |
| K163530 | PrisMax Control Unit | May 3, 2017 | Substantially Equivalent |
| K130531 | ULTRAFUSE | Apr 8, 2014 | Substantially Equivalent |
| K132734 | NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS | Oct 8, 2013 | Substantially Equivalent |
| K130245 | LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO | Mar 1, 2013 | Substantially Equivalent |
| K123874 | INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S | Jan 10, 2013 | Substantially Equivalent |
| K123868 | INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET | Jan 8, 2013 | Substantially Equivalent |
| K121092 | FLOWEASE [SUBCUTANEOUS] INFUSION SET | Jun 29, 2012 | Substantially Equivalent |
| K113227 | NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER | Dec 8, 2011 | Substantially Equivalent |
| K111217 | ADDITIVE CAP | Jun 14, 2011 | Substantially Equivalent |