Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FJK — Predicate Candidate Screening
77 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
348 days90th percentile
77clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252423 | NovaLine Tubing Set for Hemodialysis (BL 124) | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2026-05-15 | 287 | 0 |
| K251341 | VITAL Tubing Sets for Hemodialysis | Vital Healthcare Sdn. Bhd. | 2026-01-16 | 261 | 0 |
| K251442 | TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) | Ningbo Tianyi Medical Appliance Co., Ltd. | 2025-10-02 | 146 | 0 |
| K243607 | Moda-flx Hemodialysis Systemâ„¢ Cartridge (102121-001 ) | Diality, Inc. | 2024-12-20 | 29 | 0 |
| K213992 | CombiSet Hemodialysis Blood Tubing Set | Fresenius Medical Care Renal Therapies Group, LLC | 2023-05-31 | 526 | 0 |
| K210782 | Tablo Cartridge | Outset Medical, Inc. | 2021-11-26 | 255 | 0 |
| K202796 | SANSIN Tubing Sets for Hemodialysis | Jiangxi Sanxin Medtec Co., Ltd. | 2021-09-06 | 348 | 0 |
| K201866 | NovaLine Tubing Sets for Hemodialysis | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2021-03-10 | 246 | 0 |
| K171952 | Dimesol Tubing Sets for Hemodialysis | Dimesol, Inc. | 2018-03-30 | 274 | 0 |
| K161582 | DORA Tubing Sets for Hemodialysis | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2017-06-16 | 373 | 0 |
| K150304 | Oxyless Blood Tubing Set | Oxyless, Ltd. | 2016-02-24 | 383 | 0 |
| K140841 | TABLO CARTRIDGE | Home Dialysis Plus | 2014-09-11 | 162 | 0 |
| K112628 | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING | Nipro Medical Corporation | 2012-09-28 | 385 | 1 |
| K120823 | BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET | Fresenius Medical Care North America, Design Cente | 2012-06-15 | 88 | 0 |
| K100364 | GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003 | Gambro Renal Products, Inc. | 2010-11-03 | 264 | 0 |
| K090255 | BLOOD TUBING SETS (STERILE FLUID PATH) | Nxstage Medical, Inc. | 2009-02-10 | 8 | 0 |
| K080807 | BLOOD TUBING SETS (STERILE FLUID PATH) | Nxstage Medical, Inc. | 2008-07-18 | 119 | 14 |
| K070414 | GAMBRO CARTRIDGE BLOOD SETS | Gambro Renal Products | 2007-10-12 | 242 | 2 |
| K072024 | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING | Nipro Medical Corp. | 2007-10-04 | 72 | 0 |
| K063293 | EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERIL | Edwards Lifesciences Services GmbH | 2007-03-23 | 142 | 0 |
| K063290 | GAMBRO QUICKSET BLOODLINES | Gambro Renal Products | 2007-01-30 | 90 | 0 |
| K032975 | JMS BLOOD TUBING SETS | Jms North America Corp. | 2004-08-16 | 327 | 0 |
| K014140 | RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLO | Sunder Biomedical Tech. Co., Ltd. | 2002-11-18 | 336 | 0 |
| K013634 | BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK | Bioteque Corp. | 2002-07-09 | 246 | 0 |
| K012242 | FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIU | Fresenius Medical Care North America | 2001-08-16 | 30 | 0 |
| K001873 | HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 0 | Fresenius Medical Care North America | 2000-07-28 | 38 | 0 |
| K001107 | FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03- | Fresenius Medical Care North America | 2000-06-23 | 79 | 0 |
| K000451 | FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALO | Fresenius Medical Care North America | 2000-05-09 | 88 | 0 |
| K992039 | EXEL I.V. BLOOD LINE SET | Exelint Intl. Co. | 2000-02-10 | 238 | 0 |
| K992930 | BIOTEQUE HEMODIALYSIS BLOOD TUBING SET | Bioteque Corp. | 2000-02-09 | 162 | 0 |
| K982340 | EXTRACORPOREAL BLOOD CIRCUIT | Haidylena Medical Egypt | 1999-04-30 | 298 | 0 |
| K983559 | BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR | Icu Medical, Inc. | 1998-12-24 | 72 | 0 |
| K971313 | NMC HEMODIALYSIS ARTERIAL BLOOD TUBING SET | National Medical Care, Inc. | 1997-10-27 | 201 | 0 |
| K971687 | HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME | National Medical Care, Inc. | 1997-07-29 | 88 | 0 |
| K962081 | COMBILINES HEMODIALYSIS BLOOD TUBING SET | National Medical Care, Medical Products Div., Inc. | 1996-11-01 | 157 | 2 |
| K953823 | ARTERIAL VENOUS BLOOD TUBING SET | Medisystems Corp. | 1996-09-23 | 405 | 0 |
| K952631 | BRAUN HEMODIALYSIS BLOOD CIRCUITS | B.Braun Medical, Inc. | 1996-04-30 | 327 | 2 |
| K950247 | TS 564/PF | Bressler, Amery & Ross | 1995-11-17 | 301 | 0 |
| K921597 | CAVH/CVVH/CAVHD SET MODEL #HT-HF/505 | Haemotronic, Inc. | 1995-02-24 | 1057 | 0 |
| K934803 | ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS | Baxter Healthcare Corp | 1993-12-17 | 58 | 0 |
| K920797 | HEMODIALYSIS BLOOD TUBING SET | National Medical Care, Medical Products Div., Inc. | 1992-09-21 | 213 | 0 |
| K913526 | SERAFLO ARTERIAL AND VENOUS BLOODLINE SETS | Althin Medical AB an Affiliate of Baxter Intl | 1991-11-01 | 85 | 0 |
| K910558 | TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET | Terumo Medical Corp. | 1991-08-07 | 180 | 0 |
| K902426 | HEMODIALYSIS SYSTEM AND ACCESSORY | Gainor Medical Europe, Ltd. | 1990-11-20 | 173 | 0 |
| K903021 | NEGATIVE PRESSURE ARTERIAL LINE CAT. NO: 03-9630 | National Medical Care, Medical Products Div., Inc. | 1990-08-14 | 34 | 0 |
| K901688 | ARTERIAL/VENOUS BLOODLINES | National Medical Care, Medical Products Div., Inc. | 1990-08-02 | 112 | 0 |
| K896407 | HAEMOTRONIC BLOOD LINE SET | Healthcare Suppliers, Inc. | 1990-04-25 | 169 | 0 |
| K892932 | BIOPRIME TM KIT | Hospal | 1989-06-22 | 62 | 0 |
| K884243 | BLOOD TUBING SET | Mediflex Intl. | 1988-12-08 | 58 | 0 |
| K870722 | LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE | National Medical Care, Medical Products Div., Inc. | 1988-09-14 | 587 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda