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

Detector And Alarm, Arrhythmia

21 CFR 870.1025 / Cardiovascular
FDA source (opens on fda.gov)

DSI is the FDA product code for Detector And Alarm, Arrhythmia, a class II device type, regulated under 21 CFR 870.1025. As of , FDA records hold 398 510(k) clearances under this code, the most recent dated , and 82 recalls.

Classification record

Product code
DSI
Device name
Detector And Alarm, Arrhythmia
Regulation
21 CFR 870.1025
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
398
Ingested recalls
82

Clearances, product code DSI

By decision year
398 clearances under product code DSI with a decision year between 1976 and 2026, 1986 the highest year at 24.
Show the numbers
510(k) clearances under FDA product code DSI by decision year
YearClearances
19761
19772
19785
19796
19806
198114
19829
198313
198417
198522
198624
198714
198814
198920
199018
199111
199210
19934
19944
199515
19969
199722
199818
19999
200013
20019
200213
20034
20041
20055
20061
20077
20085
20096
20106
20116
20123
20131
20144
20159
20166
20182
20193
20202
20232
20241
20251
20261

Applicants with the most clearances

Product code DSI
Applicants holding the most 510(k) clearances under product code DSI
ApplicantClearances
Siemens Medical Solutions USA, Inc.27
Hewlett-Packard Co.22
Fukuda Denshi USA, Inc.19
Nihon Kohden America Inc18
GE Healthcare17
Oxford Medilog, Inc.14
Mennen Medical, Inc.13
Marquette Electronics, Inc.11
Spacelabs, Inc.11
Del Mar Avionics10

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 103 companies shown, in name order