CCPD 3 Liter Drainage Set

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K810671 ↗

FDA Product Code

KDJ

Device Class

Class II

Regulation

21 CFR Part 876.5630

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Amp Closed Urinary Drainage Bag, 1011 & 1011N

  Class II

  FDA 510(k) K861251 Active Cleared 17 Apr 1986

• Cycler W/5 or 10 Hr. Fill/Dwell Timer

  Class II

  FDA 510(k) K800496 Active Cleared 21 Jul 1980

• Set, Administration, Manual, Dialysis

  Class II

  FDA 510(k) K780957 Active Cleared 6 Jul 1978

• Ccpd Cycler Set W/5 Pronged Connector

  Class II

  FDA 510(k) K822545 Active Cleared 13 Oct 1982

• Amp Mark IV Infusion Pump

  Class II

  FDA 510(k) K811918 Active Cleared 20 Jul 1981

• Ampercide Disinfectant Accessory to -

  Class II

  FDA 510(k) K830881 Active Cleared 2 Jun 1983

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• What is the CCPD 3 Liter Drainage Set used for?

  The CCPD 3 Liter Drainage Set is a disposable peritoneal dialysis administration set designed for use in continuous cycling peritoneal dialysis (CCPD) therapy to facilitate fluid exchange during treatment.

• Is the CCPD 3 Liter Drainage Set sterile and intended for single use?

  Yes, the device is described as a disposable set, indicating it is intended for single use and supplied sterile to ensure patient safety during peritoneal dialysis procedures.

• What regulatory pathway was used for the CCPD 3 Liter Drainage Set?

  The device received FDA 510(k) clearance under traditional review, demonstrating substantial equivalence to a predicate device, with clearance granted on March 24, 1981, under K810671.

• Who manufactures the CCPD 3 Liter Drainage Set and where is it produced?

  The CCPD 3 Liter Drainage Set is manufactured by American Medical Products, Inc. in McHenry, Illinois, USA, as specified in the device’s authorization and establishment registration data.