ADR-10600(ADR 400),10601 (Adr 300)
FDA 510(k) K791342 · Physio-Control Corp.
510(k) numberK791342
Submission
- Device name
- ADR-10600(ADR 400),10601 (Adr 300)
- Applicant
- Physio-Control Corp.
Mchenry, IL, US - Received
- July 17, 1979
- Decision date
- November 16, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FKX – System, Peritoneal, Automatic Delivery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5630
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FKX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250523 | Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard…FKX · Traditional | Simergent, LLC | 10/02/2025SE |
| K243371 | Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1FKX · Traditional | Byonyks Pvt, Ltd. | 05/16/2025SE |
| K220935 | Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision…FKX · Traditional | Iren-Medical, Ltd. | 12/29/2022SE |
| K222318 | Fresenius Liberty Select CyclerFKX · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 10/31/2022SE |
| K212522 | Lilliput APD SystemFKX · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 04/15/2022SE |
| K212658 | CloudCath Peritoneal Dialysis Drain Set Monitoring SystemFKX · Traditional | Cloudcath | 02/09/2022SE |
| K201867 | Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the…FKX · Traditional | Baxter Healthcare Corporation | 11/19/2020SE |
| K181108 | Fresenius Liberty Select CyclerFKX · Special | Fresenius Medical Care Renal Therapies Group, LLC | 05/24/2018SE |
| K173718 | Liberty Cycler SetFKX · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/01/2018SE |
| K171652 | Fresenius Liberty Select CyclerFKX · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 09/15/2017SE |
More from Fresenius Medical Care Renal Therapies Group, LLC
| 510(k) | Device | Decision |
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| K253099 | LIFEPAK 15 AC Power Adapter (41577-000333)MPD · Special | 10/14/2025SE |
| K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV…DSA · Traditional | 04/30/2024SE |
| K182503 | Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsLDD · Traditional | 06/03/2019SE |
| K142430 | LIFEPAK 15 monitor/defibrillatorMKJ · Traditional | 12/19/2014SE |
| K130454 | Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/MonitorMKJ · Traditional | 08/21/2013SE |
| K123597 | Truecpr Coaching DeviceLIX · Traditional | 04/17/2013SE |
| K122600 | Lifepak 1000 DefibrillatorMKJ · Traditional | 10/11/2012SE |
| K103567 | Lifepak 15 Monitor/DefibrillatorMKJ · Traditional | 03/22/2011SE |
| K102972 | Lifepak 12MKJ · Special | 12/22/2010SE |
| K102757 | Lifenet SystemMSX · Special | 11/05/2010SE |
Questions and answers
When was ADR-10600(ADR 400),10601 (Adr 300) cleared by the FDA?
ADR-10600(ADR 400),10601 (Adr 300) (K791342) received a 510(k) decision of Substantially Equivalent on November 16, 1979, 122 days after the submission was received.
What is the product code of K791342?
The FDA product code is FKX – System, Peritoneal, Automatic Delivery, a Class II (moderate risk) device regulated under 21 CFR 876.5630.