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

Warwick Warwickshire, GB

QUANTA DIALYSIS TECHNOLOGIES LTD appears in FDA device records in Warwick Warwickshire, GB. FDA records list 4 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
4
PMA records
0
Recall records
0
Registered establishments
3

510(k) clearance history

FDA records hold 4 510(k) clearances for Quanta Dialysis Technologies Ltd between 2020 and 2024. The busiest year on record is 2020, with 1. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Quanta Dialysis Technologies Ltd, by decision year
YearClearances
20201
20211
20221
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K242269SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)ONWSubstantially Equivalent
K222067SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube SetKDISubstantially Equivalent
K210661SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood TubesetKDISubstantially Equivalent
K193670SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube SetKDISubstantially Equivalent

Registered establishments

FDA registered establishments for Quanta Dialysis Technologies Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30135361883013536188QUANTA DIALYSIS TECHNOLOGIES LTDThe Woods, Warwick Warwickshire CV34 5AH GB2026
30206898443020689844Quanta Dialysis Technologies LtdFford Richard Davies, St Asaph Denbighshire LL17 0LJ GB2026
30191075133019107513Quanta Dialysis Technologies, Inc.71 Cherry Hill Drive, Beverly, MA 01915 US2026No device listings on this registration

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

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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