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510(k) K823827

AMP 80/2 OUTFLOW MONITOR MODIFICATION by American Medical Products, Inc. — Product Code FKX

K823827 is an FDA 510(k) premarket notification submitted by American Medical Products, Inc. for the device "AMP 80/2 OUTFLOW MONITOR MODIFICATION". The FDA issued a decision of Substantially Equivalent on March 17, 1983. The device falls under product code FKX (System, Peritoneal, Automatic Delivery), 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
March 17, 1983
Date Received
December 20, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Peritoneal, Automatic Delivery
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)
  • K822543 — CAPD SAFE LOCK TRANSFER SET (October 13, 1982)
  • K822548 — SAFE LOCK CATHETER S-3 (October 13, 1982)
  • K822550 — SAFE LOCK TITANIUM ADAPTER SET (October 13, 1982)
  • K822545 — CCPD CYCLER SET W/5 PRONGED CONNECTOR (October 13, 1982)
  • K822546 — SAFE LOCK SEALING CAPS (October 13, 1982)
  • K822549 — CCPD CYCLER SET W/5 PRONGED SAFE LOCK (October 13, 1982)

Other clearances for product code FKX

  • K250523 — Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes S (October 2, 2025)
  • K243371 — Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 (May 16, 2025)
  • K220935 — Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supe (December 29, 2022)
  • K222318 — Fresenius Liberty Select Cycler (October 31, 2022)
  • K212522 — Lilliput APD System (April 15, 2022)
  • K212658 — CloudCath Peritoneal Dialysis Drain Set Monitoring System (February 9, 2022)
  • K201867 — Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the (November 19, 2020)
  • K181108 — Fresenius Liberty Select Cycler (May 24, 2018)
  • K173718 — Liberty Cycler Set (May 1, 2018)
  • K171652 — Fresenius Liberty Select Cycler (September 15, 2017)

FDA data resources