FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INPERSOL PERITONEAL DIALSIS CYCLER SET
K Number: K823217
·
Decision Nov 30, 1982
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
82
Applicant Total
883
Review Days
33
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
- INPERSOL PERITONEAL DIALSIS CYCLER SET
- K Number
- K823217
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- October 28, 1982
- Decision Date
- November 30, 1982
- Product Code
- FKX
- 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 |
|---|---|---|---|
| FKX | System, Peritoneal, Automatic Delivery | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FKX), ordered by most recent decision date.
Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Fresenius Liberty Select Cycler
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Lilliput APD System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CloudCath Peritoneal Dialysis Drain Set Monitoring System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Abbott Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K252424 | Anti-HCV Next | Apr 28, 2026 | Substantially Equivalent |
| K243500 | ARCHITECT iGentamicin | Jul 9, 2025 | Substantially Equivalent |
| K243168 | Alinity i Rubella IgG | Jun 20, 2025 | Substantially Equivalent |
| K243283 | Alinity h-series System | Feb 20, 2025 | Substantially Equivalent |
| K233932 | Alinity i Toxo IgM | Aug 30, 2024 | Substantially Equivalent |
| K232669 | TBI | Sep 29, 2023 | Substantially Equivalent |
| K222850 | HAVAb IgG II | Aug 10, 2023 | Substantially Equivalent |
| K220031 | Alinity h-series System | Aug 4, 2023 | Substantially Equivalent |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 System | Jul 14, 2023 | Substantially Equivalent |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | Jun 5, 2023 | Substantially Equivalent |