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

Oximeter

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

DQA is the FDA product code for Oximeter, a class II device type, regulated under 21 CFR 870.2700. As of , FDA records hold 726 510(k) clearances under this code, the most recent dated , and 128 recalls.

Classification record

Product code
DQA
Device name
Oximeter
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
No
Ingested clearances
726
Ingested recalls
128

Clearances, product code DQA

By decision year
726 clearances under product code DQA with a decision year between 1978 and 2026, 2009 the highest year at 35.
Show the numbers
510(k) clearances under FDA product code DQA by decision year
YearClearances
19781
19791
19822
19831
19842
19868
198718
198824
198914
199026
199117
199210
199311
199416
199512
199611
199722
199816
199913
200027
200121
200228
200319
200432
200520
200626
200720
200822
200935
201029
201115
201214
201315
201411
201513
201614
20179
201818
201919
202015
202110
202220
202313
202414
202515
20267

Applicants with the most clearances

Product code DQA
Applicants holding the most 510(k) clearances under product code DQA
ApplicantClearances
Masimo Corporation77
Nonin Medical, Inc42
Medtronic, Inc.31
Beijing Choice Electronic Technololgy Co., Ltd.21
GE Healthcare14
Dolphin Medical, Inc.12
Bci Intl., Inc.11
Nellcor, Inc.11
Unimed Medical Supplies Inc11
Beijing Choice Electronic Technology Co., Ltd.10

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 368 companies shown, in name order