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

Accessory To Continuous Ventilator (Respirator)

21 CFR 868.5895 / Anesthesiology
FDA source (opens on fda.gov)

MOD is the FDA product code for Accessory To Continuous Ventilator (Respirator), a class II device type, regulated under 21 CFR 868.5895. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
MOD
Device name
Accessory To Continuous Ventilator (Respirator)
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
16
Ingested recalls
2

Clearances, product code MOD

By decision year
16 clearances under product code MOD with a decision year between 1995 and 2026, 1995 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code MOD by decision year
YearClearances
19953
19961
20011
20021
20031
20041
20052
20091
20171
20251
20263

Applicants with the most clearances

Product code MOD
Applicants holding the most 510(k) clearances under product code MOD
ApplicantClearances
Cardiopulmonary Corp.2
Air Safety, Ltd.1
Bicore Monitoring Systems1
Breas Medical AB1
Convergence Medical Sciences , Ltd.1
Corvent Medical Inc.1
ZOLL Medical Corporation1
Innovision Medical Technologies, LLC1
Mediserve Information Systems, Inc.1
Newport Medical Instruments, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code