Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KOC — Predicate Candidate Screening
182 FDA 510(k) clearances under this product code; the 50 most recent screened below.
58 daysmedian FDA review time
268 days90th percentile
182clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242176 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLO | NIKKISO CO., LTD. | 2025-05-15 | 295 | 0 |
| K242479 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLO | NIKKISO CO., LTD. | 2025-05-15 | 267 | 0 |
| K231589 | Blood Tubing Lines for Hemodialysis AV06C-E | NIKKISO CO., LTD. | 2023-07-28 | 57 | 0 |
| K230514 | Blood Tubing Lines for Hemodialysis AL Series (Archloop), Bl | NIKKISO CO., LTD. | 2023-06-16 | 112 | 0 |
| K201207 | CombiSet SMARTECH Hemodialysis Blood Tubing Set with attache | Fresenius Medical Care Renal Therapies Group, LLC | 2020-09-18 | 136 | 0 |
| K172238 | CAREline Airless Hemodialysis Blood Tubing Sets | Fresenius Medical Care Renal Therapies Group, LLC | 2017-12-14 | 141 | 0 |
| K160749 | CRIT-LINE III Blood Chamber II | Fresenius Medical Care Renal Therapies Group, LLC | 2016-04-15 | 28 | 0 |
| K152953 | CRIT-LINE CLIP (CLIC) BLOOD CHAMBER | Fresenius Medical Care North America | 2015-11-05 | 29 | 0 |
| K141997 | CRIT-LINE IV SYSTEM | Fresenius Medical Care | 2015-04-01 | 252 | 0 |
| K141281 | CRIT-LINE CLIP (CLIC) BLOOD CHAMBER | Fresenius Medical Care Renal Therapies Group, LLC | 2014-08-14 | 90 | 0 |
| K121599 | CRIT-LINE CLIP (CLIC) | Fresenius Medical Care-North America | 2012-11-09 | 161 | 0 |
| K082719 | NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODE | NIKKISO CO., LTD. | 2009-03-30 | 194 | 0 |
| K081740 | HEMOBAND, MODELS HB-NS AND HB-NSXL | Innovations For Access, Inc. | 2009-03-12 | 266 | 0 |
| K082758 | PRISMAFLO II | Stihler Electronic GmbH | 2008-12-19 | 91 | 0 |
| K081043 | LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT | Nxstage Medical, Inc. | 2008-07-07 | 84 | 0 |
| K071909 | PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R | Barkey GmbH & Co. KG | 2007-10-18 | 99 | 0 |
| K030456 | VASC-ALERT | Vasc-Alert, LLC | 2003-07-11 | 150 | 0 |
| K022536 | \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDA | Fresenius Medical Care | 2002-10-30 | 90 | 3 |
| K020103 | PRISMAFLO | Stihler Electronic GmbH | 2002-07-24 | 194 | 0 |
| K003712 | MODIFICATION TO MALE TO MALE LUER ADAPTER | Molded Products, Inc. | 2001-05-16 | 166 | 2 |
| K010268 | FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-900 | Fresenius Medical Care North America | 2001-04-27 | 88 | 0 |
| K002816 | TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV | Transonic Systems, Inc. | 2000-11-22 | 72 | 0 |
| K002372 | ACCESS ALERT GAUGE | Medisystems Corp. | 2000-10-25 | 82 | 0 |
| K994306 | REVERSO | Medisystems Corp. | 2000-03-20 | 90 | 0 |
| K983707 | JMS DIALYZER PRIMING SET | Jms Co., Ltd. | 1999-01-08 | 79 | 0 |
| K972206 | NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR | Nipro Medical Corp. | 1997-11-26 | 168 | 0 |
| K971860 | MEDISYSTEMS DIALYSIS PRIMING SETS | Medisystems Corp. | 1997-08-18 | 90 | 0 |
| K954676 | NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS | Nissho Corp. | 1997-03-04 | 511 | 0 |
| K964041 | CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS | Robert R. Stevens | 1997-01-30 | 114 | 0 |
| K955277 | ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSIS | Baxter Healthcare Corp | 1996-02-16 | 91 | 0 |
| K952572 | DIALYSIS ADMINISTRATION KITS | B.Braun Medical, Inc. | 1996-01-11 | 220 | 0 |
| K950282 | KARL STORZ MODIFIED VERESS NEEDLE AND CANNULA | KARL STORZ Endoscopy-America, Inc. | 1995-04-05 | 71 | 0 |
| K941851 | DUAL LUMEN CATHETER (DLC) TRAY | Neostar Medical Technologies, Inc. | 1995-03-13 | 333 | 1 |
| K941543 | DIAL MEDICAL KIT | Regulatory & Marketing Services, Inc. | 1995-02-16 | 323 | 0 |
| K941803 | PRISM MEDICAL CUSTOM DIALYSIS KIT | Medical Device Support Services | 1995-01-30 | 293 | 0 |
| K935958 | CRIT-LINE BLOOD CHAMBER WITH E-BEAM | In-Line Diagnostics Corp. | 1995-01-19 | 419 | 1 |
| K926374 | SILICONE CATHETER REPAIR KITS | Akcess Medical Products, Inc. | 1994-10-07 | 654 | 0 |
| K925522 | CENTRYSYSTEM 3 WITH CHARTS/BP OPTION | C.G.H. Medical, Inc. | 1994-09-30 | 697 | 0 |
| K925654 | CD HOME DIALYSERVICE HEMODIALYSIS TRAY | Cd Medical, Inc. | 1994-03-30 | 506 | 0 |
| K924436 | BARD UROTRACK II MONITORING | C.R. Bard, Inc. | 1994-03-15 | 560 | 0 |
| K911230 | RS-1000 | Cp Medical | 1993-06-09 | 812 | 0 |
| K920671 | DIGI -FLOW | D and D Technology, Inc. | 1993-01-28 | 350 | 0 |
| K920614 | HEMO-BAND | Innovations IN Access, Inc. | 1992-07-27 | 167 | 0 |
| K912374 | BARD(R) UROTACK(R) 210 MONITORING SYSTEM | C.R. Bard, Inc. | 1992-03-31 | 307 | 0 |
| K913361 | DRAIN/PRIMING/RECIRCULATION BAG | Haemotronic, Inc. | 1992-03-30 | 245 | 0 |
| K911315 | EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT | Baxter Healthcare Corp | 1991-10-30 | 218 | 1 |
| K913483 | MINNILERT(R) PRESSURE MONITOR | Minntech Corp. | 1991-09-27 | 52 | 0 |
| K911106 | MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG | Baxter Healthcare Corp | 1991-05-28 | 77 | 0 |
| K910641 | INTRODUCER NEEDLES | Akcess Medical Products, Inc. | 1991-04-29 | 75 | 0 |
| K910321 | Y ADAPTOR | Akcess Medical Products, Inc. | 1991-04-16 | 82 | 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