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510(k) K223874

BAROguard by Paragonix Technologies — Product Code KDN

K223874 is an FDA 510(k) premarket notification submitted by Paragonix Technologies for the device "BAROguard". The FDA issued a decision of Substantially Equivalent on August 15, 2023. The device falls under product code KDN (System, Perfusion, Kidney), a Class II device regulated under 21 CFR 876.5880. Paragonix Technologies has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2023
Date Received
December 23, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Perfusion, Kidney
Device Class
Class II
Regulation Number
876.5880
Review Panel
GU
Submission Type

Other clearances by Paragonix Technologies

  • K254305 — BAROguard Donor Lung Preservation System (January 30, 2026)
  • K234060 — KIDNEYvault Portable Renal Perfusion System (October 23, 2024)
  • K201048 — SherpaPak Pediatric Liver Transport System (July 2, 2020)
  • K191440 — Paragonix SherpaPak Pancreas Transport System (December 20, 2019)
  • K182735 — Paragonix SherpaPak Cardiac Transport System (October 19, 2018)
  • K180194 — SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System (March 30, 2018)
  • K143054 — Sherpa Pak Kidney Transport System (November 25, 2014)
  • K143074 — Sherpa Pak Cardiac Transport System (November 25, 2014)
  • K133694 — SHERPA PAK TRANSPORTER (May 23, 2014)
  • K133432 — SHERPA PAK CARDIAC TRANSPORT SYSTEM (February 21, 2014)

Other clearances for product code KDN

  • K260456 — VI°Port™ Liver Preservation System (June 1, 2026)
  • K254305 — BAROguard Donor Lung Preservation System (January 30, 2026)
  • K243618 — EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) (June 17, 2025)
  • K243870 — X°Port Lung Preservation System; X°Port Lung Preservation Solution (May 1, 2025)
  • K243998 — DCX Disposable Cassette (DCX) (April 25, 2025)
  • K243384 — Belzer UW® Cold Storage Solution (BTLBUW-001) (March 31, 2025)
  • K243840 — Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) (March 26, 2025)
  • K240650 — LungProtect (November 26, 2024)
  • K234060 — KIDNEYvault Portable Renal Perfusion System (October 23, 2024)
  • K230193 — Servator P Plus SALF Solution (September 21, 2023)

FDA data resources