Chrysalis Intelligence · Sponsors · Paragonix Technologies, Inc.

Paragonix Technologies, Inc.

Waltham, MA, US · 4 510(k) clearances · 1 recalls

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Total clearances
4
2020-07-02 → 2026-01-30
Last 12 months
1
Product codes
1
Most recent
2026-01-30
Name variants in FDA filings: Paragonix Technologies / Paragonix Technologies, Inc.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
KDN System, Perfusion, Kidney Class II Gastroenterology, Urology 4 2026-01-30
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
1
Most recent
2026-07-20
DateSeverityStatusRecall # ProductCodeReason
2026-07-20 Class II Ongoing Z-2967-2026 Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001 — Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservati…
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2026-01-30 K254305 BAROguard Donor Lung Preservation System KDN Class II Gastroenterology, Urology
2024-10-23 K234060 KIDNEYvault Portable Renal Perfusion System KDN Class II Gastroenterology, Urology
2023-08-15 K223874 BAROguard KDN Class II Gastroenterology, Urology
2020-07-02 K201048 SherpaPak Pediatric Liver Transport System KDN Class II Gastroenterology, Urology
Data source: openFDA · Generated 2026-10-08 10:51 · Last ingest 2026-10-08T14:51:39.242493 · Pipeline: Chrysalis Intelligence