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

Adjunctive Open Loop Fluid Therapy Recommender

21 CFR 870.5600 / Cardiovascular
FDA source (opens on fda.gov)

QMS is the FDA product code for Adjunctive Open Loop Fluid Therapy Recommender, a class II device type, regulated under 21 CFR 870.5600. FDA's definition for this code reads: "The adjunctive open loop fluid therapy recommender is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict a patient’s estimated response to fluid therapy. The device is intended for adjunctive use with other physical vital sign parameters and patient information and is...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QMS
Device name
Adjunctive Open Loop Fluid Therapy Recommender
FDA definition
The adjunctive open loop fluid therapy recommender is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict a patient’s estimated response to fluid therapy. The device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
Regulation
21 CFR 870.5600
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code QMS

By decision year
2 clearances under product code QMS with a decision year between 2020 and 2024, 2020 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QMS by decision year
YearClearances
20201
20241

Applicants with the most clearances

Product code QMS
Applicants holding the most 510(k) clearances under product code QMS
ApplicantClearances
Edwards Lifesciences LLC2

Companies listing this code with FDA

Companies whose registered establishments list this code