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

Oximeter, Tissue Saturation

21 CFR 870.2700 / Cardiovascular
FDA source (opens on fda.gov)

MUD is the FDA product code for Oximeter, Tissue Saturation, a class II device type, regulated under 21 CFR 870.2700. As of , FDA records hold 74 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
MUD
Device name
Oximeter, Tissue Saturation
Regulation
21 CFR 870.2700
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
74
Ingested recalls
7

Clearances, product code MUD

By decision year
74 clearances under product code MUD with a decision year between 1998 and 2026, 2019 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code MUD by decision year
YearClearances
19981
20022
20042
20052
20064
20084
20094
20104
20112
20126
20132
20145
20153
20164
20173
20183
20197
20202
20212
20222
20232
20245
20252
20261

Applicants with the most clearances

Product code MUD
Applicants holding the most 510(k) clearances under product code MUD
ApplicantClearances
Cas Medical Systems, Inc.9
Hutchinson Technology, Inc.8
Vioptix, Inc.8
Masimo Corporation6
Nonin Medical, Inc5
Reflectance Medical, Inc.5
Edwards Lifesciences LLC4
Kent Imaging Inc4
Somanetics Corp.4
Or-Nim Medical, Ltd.3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 52 companies shown, in name order