510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Paragonix Technologies Inc.

Waltham, MA, US

PARAGONIX TECHNOLOGIES, INC. appears in FDA device records in Waltham, MA. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
12
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 12 510(k) clearances for Paragonix Technologies Inc. between 2013 and 2026. The busiest year on record is 2014, with 4. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Paragonix Technologies Inc., by decision year
YearClearances
20131
20144
20182
20191
20201
20231
20241
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K254305BAROguard Donor Lung Preservation SystemKDNSubstantially Equivalent
K234060KIDNEYvault Portable Renal Perfusion SystemKDNSubstantially Equivalent
K223874BAROguardKDNSubstantially Equivalent
K201048SherpaPak Pediatric Liver Transport SystemKDNSubstantially Equivalent
K191440Paragonix SherpaPak Pancreas Transport SystemKDNSubstantially Equivalent
K182735Paragonix SherpaPak Cardiac Transport SystemMSBSubstantially Equivalent
K180194SherpaPak Cardiac Transport System and SherpaPak Kidney Transport SystemMSBSubstantially Equivalent
K143074Sherpa Pak Cardiac Transport SystemMSBUnknown
K143054Sherpa Pak Kidney Transport SystemKDNUnknown
K133694SHERPA PAK TRANSPORTERKDNSubstantially Equivalent
K133432SHERPA PAK CARDIAC TRANSPORT SYSTEMMSBSubstantially Equivalent
K123326SHERPA PAK CARDIAC TRANSPORT SYSTEMMSBSubstantially Equivalent

Registered establishments

FDA registered establishments for Paragonix Technologies Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30111755553011175555PARAGONIX TECHNOLOGIES, INC.950 Winter Street, North, Waltham, MA 02451 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2967-2026Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain