510(k) K012242
- Device
- FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS
- Applicant
- FRESENIUS MEDICAL CARE NORTH AMERICA
- 510(k) number
- K012242
- Product code
- FJK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-08-16
- Date received
- 2001-07-17
- Regulation
- 876.5820
- Classification name
- Set, Tubing, Blood, With And Without Anti-regurgitation Valve
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ARTHUR EILINSFELD
- Address
- 95 Hayden Ave. Lexington MA US 02420 02420
FDA Registration Numbers#
- 3000247873
- 1018470
- 3006795797
- 3005162618
- 3017636737
- 9617594
- 9611823
- 2029275
- 2024024
- 8041145
- 3017552925
- 3013546453
- 3043534762
- 3035708507
- 9611369
- 3038138522
- 3032143970
- 3043014136
- 3013217742
- 3011163668
- 3006755813
- 3013764800
- 3038195011
- 3030446844
- 3010355846
- 3015349756
- 3020689844
- 3004111573
- 3013536188
- 3016096143
- 3008044552
- 9614279
- 2025816
- 3006849754
- 8030665
- 2521402
- 2032112
- 1649518
- 3032828299
- 2011171
- 3009746061
- 3014936217
- 3004530184
- 3015335038
- 9680579
- 3042158867
- 8030638
- 3004960482
- 3005578748
- 3010377171
- 9616419
- 3013671177
- 2028411
- 3003589956
- 1225714
- 3005246939
- 3014279513
- 9611824
- 2032098
- 8030639
- 1650907
- 3010291427
Source Documents#
Other 510(k) Records For Product Code FJK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252423 | NovaLine Tubing Set for Hemodialysis (BL 124) | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2026-05-15 |
| K251341 | VITAL Tubing Sets for Hemodialysis | Vital Healthcare Sdn. Bhd. | 2026-01-16 |
| K251442 | TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) | Ningbo Tianyi Medical Appliance Co., Ltd. | 2025-10-02 |
| K243607 | Moda-flx Hemodialysis System™ Cartridge (102121-001 ) | Diality, Inc. | 2024-12-20 |
| K213992 | CombiSet Hemodialysis Blood Tubing Set | Fresenius Medical Care Renal Therapies Group, LLC | 2023-05-31 |
| K210782 | Tablo Cartridge | Outset Medical, Inc. | 2021-11-26 |
| K202796 | SANSIN Tubing Sets for Hemodialysis | Jiangxi Sanxin Medtec Co., Ltd. | 2021-09-06 |
| K201866 | NovaLine Tubing Sets for Hemodialysis | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2021-03-10 |
| K171952 | Dimesol Tubing Sets for Hemodialysis | Dimesol, Inc. | 2018-03-30 |
| K161582 | DORA Tubing Sets for Hemodialysis | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2017-06-16 |
| K150304 | Oxyless Blood Tubing Set | Oxyless, Ltd. | 2016-02-24 |
| K140841 | TABLO CARTRIDGE | Home Dialysis Plus | 2014-09-11 |
| K112628 | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET | Nipro Medical Corporation | 2012-09-28 |
| K120823 | BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS | Fresenius Medical Care North America, Design Cente | 2012-06-15 |
| K100364 | GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 | Gambro Renal Products, Inc. | 2010-11-03 |
Legacy Summary#
summary
FDA Review#
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