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

Pump, Infusion, Insulin Bolus

21 CFR 880.5725 / General Hospital
FDA source (opens on fda.gov)

OPP is the FDA product code for Pump, Infusion, Insulin Bolus, a class II device type, regulated under 21 CFR 880.5725. FDA's definition for this code reads: "The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OPP
Device name
Pump, Infusion, Insulin Bolus
FDA definition
The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus.
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
1

Clearances, product code OPP

By decision year
7 clearances under product code OPP with a decision year between 2010 and 2026, 2010 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code OPP by decision year
YearClearances
20102
20121
20171
20242
20261

Applicants with the most clearances

Product code OPP
Applicants holding the most 510(k) clearances under product code OPP
ApplicantClearances
Calibra Medical, Inc.3
CeQur SA3
Lifescan Europe, A Division of Cilag GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code