510(k) Report

FDA applicant

Paragonix Technologies, Inc.

Braintree, MA12 decisions2013–20261 recall

FDA records 12 decisions for Paragonix Technologies, Inc. (Braintree, MA) from 2013 to 2026: 12 510(k) clearances. Most are in product codes KDN (System, Perfusion, Kidney) and MSB (System And Accessories, Isolated Heart…). Its devices cite 18 predicates, 6 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Paragonix Technologies”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Paragonix Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2013: 12014: 42018: 22019: 12020: 12023: 12024: 12026 (partial year): 1
2013high 4 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2026

2026 (partial year): 1
2013high 1 (2026) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Paragonix Technologies, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Paragonix Technologies, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • KDNSystem, Perfusion, Kidney7decisions
  • MSBSystem And Accessories, Isolated Heart, Transport And Preservation5decisions

Whose devices does it build on?

Its devices cite 18 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 6 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K133694Sherpa Pak TransporterParagonix Technologies, Inc. · 20142cite it
  • K133432Sherpa Pak Cardiac Transport SystemParagonix Technologies, Inc. · 20142cite it
  • K123326Sherpa Pak Cardiac Transport SystemParagonix Technologies, Inc. · 20132cite it
  • K180194SherpaPak Cardiac Transport System and SherpaPak Kidney Transport SystemParagonix Technologies, Inc. · 20181cites it

What has FDA decided for it lately?

  • K254305BAROguard Donor Lung Preservation SystemParagonix Technologies, Inc. · 2026
  • K234060KIDNEYvault Portable Renal Perfusion SystemParagonix Technologies · 20241 recall
  • K223874BAROguardParagonix Technologies · 2023
  • K201048SherpaPak Pediatric Liver Transport SystemParagonix Technologies · 2020
  • K191440Paragonix SherpaPak Pancreas Transport SystemParagonix Technologies · 2019
  • K182735Paragonix SherpaPak Cardiac Transport SystemParagonix Technologies · 2018
  • K180194SherpaPak Cardiac Transport System and SherpaPak Kidney Transport SystemParagonix Technologies, Inc. · 2018
  • K143054Sherpa Pak Kidney Transport SystemParagonix Technologies, Inc. · 2014

All 7 as Paragonix Technologies, Inc. →All 5 as Paragonix Technologies →

What has been recalled?

1 recall linked to its devices; the latest:

  • K234060Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF#…Jul 20, 2026Class II