Safe Lock Sealing Cap L
FDA 510(k) K822544 · American Medical Products, Inc.
510(k) numberK822544
Submission
- Device name
- Safe Lock Sealing Cap L
- Applicant
- American Medical Products, Inc.
Freehold, NJ, US - Received
- August 23, 1982
- Decision date
- October 13, 1982
- 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 |
|---|---|---|
| K922290 | Single-Step Pregnancy, HCG TestJHI · Traditional | 07/09/1992SE |
| K862221 | E-Z CleanGEI · Traditional | 09/12/1986SE |
| K861251 | Amp Closed Urinary Drainage Bag, 1011 & 1011NKNX · Traditional | 04/17/1986SE |
| K830881 | Ampercide Disinfectant Accessory to -FKX · Traditional | 06/02/1983SE |
| K823827 | Amp 80/2 Outflow Monitor ModificationFKX · Traditional | 03/17/1983SE |
| K822551 | Amp Capd Unispike Aministration SetFKK · Traditional | 10/13/1982SE |
| K822550 | Safe Lock Titanium Adapter SetFKX · Traditional | 10/13/1982SE |
| K822549 | CCPD Cycler Set W/5 Pronged Safe LockFKX · Traditional | 10/13/1982SE |
| K822548 | Safe Lock Catheter S-3FKX · Traditional | 10/13/1982SE |
| K822546 | Safe Lock Sealing CapsFKX · Traditional | 10/13/1982SE |
Questions and answers
When was Safe Lock Sealing Cap L cleared by the FDA?
Safe Lock Sealing Cap L (K822544) received a 510(k) decision of Substantially Equivalent on October 13, 1982, 51 days after the submission was received.
What is the product code of K822544?
The FDA product code is FKX – System, Peritoneal, Automatic Delivery, a Class II (moderate risk) device regulated under 21 CFR 876.5630.