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

System, Hemodialysis, Access Recirculation Monitoring

21 CFR 876.5820 / Gastroenterology, Urology
FDA source (opens on fda.gov)

MQS is the FDA product code for System, Hemodialysis, Access Recirculation Monitoring, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
MQS
Device name
System, Hemodialysis, Access Recirculation Monitoring
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
18
Ingested recalls
1

Clearances, product code MQS

By decision year
18 clearances under product code MQS with a decision year between 1996 and 2023, 1996 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code MQS by decision year
YearClearances
19963
19973
19982
19992
20002
20022
20041
20131
20191
20231

Applicants with the most clearances

Product code MQS
Applicants holding the most 510(k) clearances under product code MQS
ApplicantClearances
In-Line Diagnostics Corp.5
Transonic Systems Inc4
Hewlett-Packard Co.2
Cobe Renal Care, Inc.1
Dosis, Inc.1
Fresenius USA, Inc.1
H&H Control Systems1
Physician Software Systems, LLC1
Physicians Software Systems, LLC1
Vasc-Alert, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code