DRI-LYTE

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

510(k) Number

K780353 ↗

FDA Product Code

KPO

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Foam Nose

  Class I

  FDA 510(k) K840399 Active Cleared 16 Mar 1984

• Isotonic Diluent

  Class I

  FDA 510(k) K781008 Active Cleared 28 Jun 1978

• Hi-Lo Temp Thermocouple to Thermister Adaptor

  Class II

  FDA 510(k) K844201 Active Cleared 4 Mar 1985

• Glucose Reagent (O-Toluidine)

  Class II

  FDA 510(k) K771314 Active Cleared 3 Aug 1977

• Ria Quant C-Peptide Kit

  Class I

  FDA 510(k) K812689 Active Cleared 6 Oct 1981

• Hi-Lo Temp(R) Model 8700 Patient Temp Monitor

  Class II

  FDA 510(k) K874568 Active Cleared 6 Jan 1988

See all devices from Mallinckrodt Critical Care →

• What is DRI-LYTE used for?

  DRI-LYTE is a dialysate concentrate used in the preparation of dialysate solution for hemodialysis treatment. It is reconstituted from liquid or powder form to create the solution that removes waste and excess fluid from blood during dialysis.

• How is DRI-LYTE supplied and prepared for use?

  DRI-LYTE is supplied as a concentrate in either liquid or powder form, requiring reconstitution with water to prepare the final dialysate solution used in hemodialysis machines. This allows for flexible storage and on-site mixing based on clinical needs.

• Is DRI-LYTE intended for single-use or multiple uses?

  DRI-LYTE is a concentrate intended for multiple uses after reconstitution; once mixed into dialysate solution, it is used in a single hemodialysis treatment session and then discarded, as the prepared dialysate is not reused.

• What regulatory pathway was used for DRI-LYTE's market authorization?

  DRI-LYTE received traditional 510(k) clearance from the FDA on April 5, 1978 (K780353), based on demonstration of substantial equivalence to a legally marketed predicate device under regulation 876.5820.