Product code KDJ— Gastroenterology, Urology
ABBOTT SMART CAP
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 113
Adverse events under product code KDJ
product code KDJ- Death
- 298
- Injury
- 9,221
- Malfunction
- 8,438
- Other
- 1
- Total
- 17,958
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code KDJ
1–100 of 113- K250404 — staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 6 inch; staysafe® catheter extension set with Luer-Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 18 inch; staysafe® to Luer-Lock Adapter, 4 inch
- K231849 — MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483
- K214016 — 15L Cycler Drainage Bag
- K192705 — MiniCap Extended Life PD Transfer Sets
- K173593 — staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch
- K173651 — Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
- K173363 — Cycler Drain Bag Set
- K151620 — Firefly Peritoneal Dialysis Connector Disinfection System
- K152129 — FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution
- K152675 — EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER
- K124024 — APD LUER-LOCK ADAPTER
- K083542 — FRESENIUS STERILE STAY SAFE CAP
- K042900 — K.E.P. CONNECTOR AND CLIP
- K041792 — FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211
- K031676 — HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q
- K022412 — FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR
- K974387 — PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE
- K972579 — HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE
- K972731 — NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET
- K963668 — MEDISYSTEMS PERITONEAL DIALYSIS SETS
- K961825 — ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493
- K945567 — QC CAP
- K930843 — RAPID DISCONNECT Y-SET, CAT. NO. 48-7000
- K921818 — ABBOTT SMART CAP
- K925403 — BAXTER APD 12' EXTENSION LINE
- K921052 — FRESENIUS VARIABLE FILL MONITOR
- K920029 — DEXTROLYTE II CAPD TRNSFER SET
- K920586 — DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET
- K915628 — DEXTROLYTE II PERITONEAL DIALYSIS PUMP
- K915304 — ABBOTT SMART CAP
- K912208 — FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE
- K904806 — CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR
- K900295 — PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES
- K902526 — CAPD DISPOSABLE DISCONNECT Y-SET CODE: 5C4481
- K903869 — 90/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET
- K902451 — LONG-LIFE Y-SET CAT. NO. 48-6366-8
- K900106 — CLOSED DISCONNECT SYSTEM
- K895792 — DEXTROLYTE II CAPD TRANSFER SET - NO. 48-4009-6
- K895992 — CATHETER EXTENSION SET CAT. NO. 48-3027-9
- K895990 — DEXTROLYTE II PERITONEAL DIALYSIS CYCLER SET
- K895991 — PERITONEAL DIALYSIS DRAINAGE SET NO. 48-0025-6
- K896599 — DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET -(8)
- K896600 — DEXTROLYTE II, SINGLE USE Y SET NO. 48-6360-1
- K900008 — DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET
- K900012 — DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET
- K900140 — DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET W/3
- K900141 — DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1100-6
- K900142 — DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1003-2
- K900226 — DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1001-6
- K900242 — DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1031-3
- K900243 — DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1015-6
- K900323 — PERITONEAL DIALYSIS CYCLER SET
- K900005 — DEXTROLYTE II, MANUAL ADMINISTRATION SET 48-1032-1
- K896956 — QUICK DISCONNECT CLAMP CATALOG NO. 48-0300-3
- K900004 — CONVERTIBLE ADAPTER CATALOG NO. 48-4039-3
- K900006 — CATHETER ADAPTER SEALING CAP NO. 48-1028-9
- K896761 — TRANSFER SET SEALING CAP, CAT. NO. 48-1027-1
- K896763 — CATHETER ADAPTER CO-PAK CATALOG NO. 48-0122-1
- K896764 — UNIVERSAL CONNECTOR CATALOG NO. 48-1025-5
- K895631 — DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C4466
- K895673 — CONNECTION SHIELDS CODES 5C4213 AND 5C4215
- K894783 — PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP
- K893712 — PERITONEAL DIALYSIS SYSTEM AND ACCESS.
- K893231 — DELCLAMP
- K892870 — PERITONEAL DIALYSIS CYCLER SET, W/5 PRONG MANIFOLD
- K892871 — PERITONEAL DIALYSIS CYCLER SET, W/8 PRONG MANIFOLD
- K892872 — PERITONEAL DIALYSIS CYCLER SET W/12 PRONG MANIFOLD
- K883393 — CAPD DISPOSABLE Y SYSTEM - DY SET
- K883239 — CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYS
- K882455 — EXTENDED LIFE CAPD SOLUTION TRANSFER SET IC4373
- K882498 — EXTENDED LIFE CAPD TRANSFER SET 5C4444
- K873984 — AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)
- K871155 — DELFLEX RIGID DRAIN CONTAINER
- K871583 — MODIFIED LABELING FOR AMUKIN-50%
- K870626 — FREEDOM SET II WITH TRIFLEX VALVE
- K871154 — DELFLEX SAFE LOCK CAPD PATIENT ASSIST DEVICE
- K871049 — CAPD Y-ADMIN. SET USED W/INPERSOL BIOCAP ADMIN.
- K871050 — CAPD ADMIN. SET USED W/INPERSOL CAPD BIOCAP Y-ADM.
- K870145 — EXTERNAL Y VALVE 5C4198
- K860700 — CAPD DISCONNECT SYSTEM 5C4182, 5C4183, 5C4186
- K860230 — CAPD TRANSFER SET SPIKE 5C4363
- K853550 — TRAVENOL CAPD Y SET 5C4354
- K852678 — CAPD TRANSFER SET FOR REDUCED FILL VOLUMES 5C4353
- K851207 — EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C4153
- K851208 — COMPACT EXCHANGE DEVICE 5C4197
- K820546 — CARD U.V. GERMICIDAL CHAMBER II
- K812802 — CAPD U.V. GERMICIDAL CONNECTION SYSTEM
- K813069 — PERITONEAL DIALYSIS CYCLER SET
- K812771 — PERITONEAL DIALYSIS DRAINAGE
- K812772 — PERITONEAL DIALYSIS CYCLER SET (8UNIT)
- K811863 — STERI-TRACT
- K812130 — SPIKE GUARD
- K811294 — GAMBRO PERITONEAL DIALYSIS FLUID LINES
- K810840 — AMP PERITONEAL DIALYSIS PREP KIT
- K810600 — CAPD EXCHANGE SET
- K810670 — CCPD CYCLER SET
- K810671 — CCPD 3 LITER DRAINAGE SET
- K803300 — INPERSOL CAPD BAG PORT CLAMP
- K801881 — INPERSOL-CAPD ADMINISTRATION SET
- K800993 — INPERSOL CAPD ADMIN. SET & CATHETER ADAP
Data sourced from openFDA. This site is unofficial and independent of the FDA.