BEUDAMED
    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: KDJ FDA class 2

    Set, Administration, For Peritoneal Dialysis, Disposable

    Gastroenterology, Urology

    View full classification →

    A disposable peritoneal dialysis administration set is a sterile, single-use assembly of tubing, connectors, and bags used to deliver and drain dialysate into and from the peritoneal cavity in patients with renal failure undergoing peritoneal dialysis as a form of renal replacement therapy. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket clearance. Product code KDJ is regulated under 21 CFR 876.5630 in the Gastroenterology, Urology medical specialty. This device is designated as life-sustaining or life-supporting, reflecting its critical role in renal replacement therapy.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch
    MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483
    15L Cycler Drainage Bag
    MiniCap Extended Life PD Transfer Sets
    stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inch
    Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
    Cycler Drain Bag Set
    Firefly Peritoneal Dialysis Connector Disinfection System
    EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER
    FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution
    APD LUER-LOCK ADAPTER
    FRESENIUS STERILE STAY SAFE CAP
    K.E.P. CONNECTOR AND CLIP
    FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211
    HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q
    FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR
    PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE
    HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE
    NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET
    MEDISYSTEMS PERITONEAL DIALYSIS SETS
    ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493
    QC CAP
    RAPID DISCONNECT Y-SET, CAT. NO. 48-7000
    ABBOTT SMART CAP
    BAXTER APD 12' EXTENSION LINE
    FRESENIUS VARIABLE FILL MONITOR
    DEXTROLYTE II CAPD TRNSFER SET
    DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET
    DEXTROLYTE II PERITONEAL DIALYSIS PUMP
    ABBOTT SMART CAP
    FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE
    CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR
    PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES
    CAPD DISPOSABLE DISCONNECT Y-SET CODE: 5C4481
    90/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET
    LONG-LIFE Y-SET CAT. NO. 48-6366-8
    CLOSED DISCONNECT SYSTEM
    CATHETER EXTENSION SET CAT. NO. 48-3027-9
    DEXTROLYTE II CAPD TRANSFER SET - NO. 48-4009-6
    DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET
    DEXTROLYTE II PERITONEAL DIALYSIS CYCLER SET
    DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET
    DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET -(8)
    DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1003-2
    DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1031-3
    DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET W/3
    DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1100-6
    DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1001-6
    PERITONEAL DIALYSIS CYCLER SET
    DEXTROLYTE II, SINGLE USE Y SET NO. 48-6360-1

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

    Popular Product Codes

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump