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510(k) K813069

PERITONEAL DIALYSIS CYCLER SET by American Medical Products, Inc. — Product Code KDJ

K813069 is an FDA 510(k) premarket notification submitted by American Medical Products, Inc. for the device "PERITONEAL DIALYSIS CYCLER SET". The FDA issued a decision of Substantially Equivalent on November 16, 1981. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), a Class II device regulated under 21 CFR 876.5630. American Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1981
Date Received
October 30, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, For Peritoneal Dialysis, Disposable
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by American Medical Products, Inc.

  • K922290 — SINGLE-STEP PREGNANCY, HCG TEST (July 9, 1992)
  • K862221 — E-Z CLEAN (September 12, 1986)
  • K861251 — AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011N (April 17, 1986)
  • K830881 — AMPERCIDE DISINFECTANT ACCESSORY TO - (June 2, 1983)
  • K823827 — AMP 80/2 OUTFLOW MONITOR MODIFICATION (March 17, 1983)
  • K822543 — CAPD SAFE LOCK TRANSFER SET (October 13, 1982)
  • K822548 — SAFE LOCK CATHETER S-3 (October 13, 1982)
  • K822549 — CCPD CYCLER SET W/5 PRONGED SAFE LOCK (October 13, 1982)
  • K822545 — CCPD CYCLER SET W/5 PRONGED CONNECTOR (October 13, 1982)
  • K822550 — SAFE LOCK TITANIUM ADAPTER SET (October 13, 1982)

Other clearances for product code KDJ

  • K250404 — stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter (April 3, 2025)
  • K231849 — MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap E (March 12, 2024)
  • K214016 — 15L Cycler Drainage Bag (March 18, 2022)
  • K192705 — MiniCap Extended Life PD Transfer Sets (October 25, 2019)
  • K173593 — stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter ext (May 21, 2018)
  • K173651 — Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set (February 14, 2018)
  • K173363 — Cycler Drain Bag Set (January 24, 2018)
  • K151620 — Firefly Peritoneal Dialysis Connector Disinfection System (January 20, 2016)
  • K152129 — FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iod (October 29, 2015)
  • K152675 — EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER A (October 29, 2015)

FDA data resources