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

Enteral Specific Transition Connectors

21 CFR 876.5980 / Gastroenterology, Urology
FDA source (opens on fda.gov)

PIO is the FDA product code for Enteral Specific Transition Connectors, a class II device type, regulated under 21 CFR 876.5980. FDA's definition for this code reads: "Facilitates enteral specific connections between AAMI/CN3(PS):2014 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors". As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
PIO
Device name
Enteral Specific Transition Connectors
FDA definition
Facilitates enteral specific connections between AAMI/CN3(PS):2014 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
9
Ingested recalls
3

Clearances, product code PIO

By decision year
9 clearances under product code PIO with a decision year between 2014 and 2024, 2015 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code PIO by decision year
YearClearances
20141
20153
20161
20171
20221
20242

Applicants with the most clearances

Product code PIO
Applicants holding the most 510(k) clearances under product code PIO
ApplicantClearances
Cedic S.r.l.2
Applied Medical Technology Inc1
Cair LGL1
Cedic S.r.l.1
Gbuk Group Limited1
Jiangsu Caina Medical Co., Ltd1
MEDLINE INDUSTRIES, LP - Northfield1
Vygon1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order