510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960817Substantially Equivalent

Hd01-Series Transonic Hemodialysis Monitor (R%,qa,co,qb,qb2)

Transonic Systems Inc, Ithaca NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960817 is the FDA 510(k) clearance record for HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2), a class II device, cleared for Transonic Systems, Inc. on under FDA product code MQS (System, Hemodialysis, Access Recirculation Monitoring). FDA records list 16 510(k) clearances for Transonic Systems, Inc., from to . As of , FDA records show one recall naming K960817.

Clearance record

Decision date
Received
(349 days to decision)
Product code
MQS System, Hemodialysis, Access Recirculation Monitoring
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Transonic Systems, Inc. 34 Dutch Mill Rd., Ithaca NY
510(k) summary
Summary
Third party review
No

Clearances, product code MQS

Trailing 12 months

FDA records hold no clearances under product code MQS in the trailing twelve months.

FDA records show no clearances under product code MQS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MQS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260