510(k) Report

510(k) · Cleared

Cleared

Corflo Anti-IV Enteral Feeding Extension Set, Models 20-1006AIV-LB and 20-1030AIV-LB

K083786510(k) TraditionalCleared Feb 20, 200963-day reviewClass II21 CFR 876.5980

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Corpak Medsystems · FPD Tube, Feeding

Cleared on Feb 20, 2009 after a 63-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 12 later devices descend from it.

Decided
Feb 20, 2009
Review
63 days
Class
Class II
Product code
FPD
Recalls
None
Predicates
0

12 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2014: 1 descendant cleared2019: 1 descendant cleared2015: 3 descendants cleared2016: 1 descendant cleared2024: 2 descendants cleared2026: 1 descendant cleared2017: 1 descendant cleared2020: 1 descendant cleared20052010201520202025
  1. This deviceK083786 Corflo Anti-IV Enteral Feeding Extension Set, Models 20-1006AIV-LB…Corpak Medsystems · 2009
  2. Descendant · cites it directly · 8 of its ownK140581 Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral…Cedic S.R.L. · 2014
  3. Descendant · cites it directly · 2 of its ownK120272 Ameritus Medical Enteral Feeding Extension SetKentec Medical, Inc. · 2012
  4. Descendant · 2 generations on · 1 of its ownK180236 VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)Vr Medical Technology Co., Ltd. · 2019
  5. Descendant · 2 generations on · 1 of its ownK150034 AMT Enteral Transition AdaptersApplied Medical Technology, Inc. · 2015 · Recalled
  6. Descendant · 2 generations on · 0 of its ownK253268 Profoject Enteral/Oral Feeding Syringe; Profoject Reusable…CMT Health PTE., Ltd. · 2026

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2012: 12014: 12015: 32016: 12017: 12019: 12020: 12024: 22026: 1
2012high 3 (2015) · low 0 (2013)2026

Most influential descendants

Showing 5 of 12 · See all
  • K140581Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition…Cedic S.R.L. · 2014 · cites it directly8descendants
  • K120272Ameritus Medical Enteral Feeding Extension SetKentec Medical, Inc. · 2012 · cites it directly2descendants
  • K180236VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)Vr Medical Technology Co., Ltd. · 2019 · 2 generations on1descendant
  • K150034AMT Enteral Transition AdaptersApplied Medical Technology, Inc. · 2015 · 2 generations on1descendant
  • K253268Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe…CMT Health PTE., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K083786Corflo Anti-IV Enteral Feeding Extension Set, Models 20-1006AIV-LB and…Corpak Medsystems2009—
+1K140581Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit…Cedic S.R.L.2014—
+1K120272Ameritus Medical Enteral Feeding Extension SetKentec Medical, Inc.2012—
+2K180236VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)Vr Medical Technology Co., Ltd.2019—
+2K150034AMT Enteral Transition AdaptersApplied Medical Technology, Inc.20151
+2K253268Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral…CMT Health PTE., Ltd.2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201410
201530
201610
201710
201910
202010
202420
202610
FIG. 1 — Lineage of K083786, 2009–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FPD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FPD device

  1. #1 K243361 Nutrifitscore 8.8 · 2 generations · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (12)

See all 12

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K140581Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition…Cedic S.R.L.20148
K120272Ameritus Medical Enteral Feeding Extension SetKentec Medical, Inc.20122

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K140581 (Cedic S.R.L., 2014) has gone furthest, with 8 descendants of its own.

How does its category compare?

All FPD devices

FPD Tube, Feeding: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · FPD

1in 2024

2007: 12008: 42009: 42010: 42011: 22012: 12013: 22019: 12024: 1
2007high 4 (2008) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPD

118in 2010

2008: 76 days median2009: 69 days median2010: 118 days median
2007high 118 (2010) · low 69 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FPD

1in 2019

2015: 12018: 32019: 1
2007high 3 (2018) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FPD

10in 2025

2007: 192008: 242009: 402010: 212011: 152012: 322013: 382014: 642015: 552016: 1022017: 342018: 302019: 192020: 312021: 242022: 192023: 552024: 412025: 10
2007high 102 (2016) · low 10 (2025)2025

MAUDE reports naming product code FPD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—019
2008476024
2009469040
20104118021
20112—015
20121—032
20132—038
20140—064
20150—155
20160—0102
20170—034
20180—330
20191—119
20200—031
20210—024
20220—019
20230—055
20241—041
20250—010
20260—0—

What is it indicated for?

The CORFLO Anti-IV Enteral Feeding Extension Set is intended to be used to deliver enteral formula from the nutritional source to the Anti IV Enteral feeding tube. The CORFLO Anti-IV Enteral Feeding Extension Set is for pediatric and neonatal use only.

Indications for use as stated in the FDA 510(k) statement.

More from Corpak Medsystems

15 FDA decisions under this applicant name. See the company

  • K142012Farrell Valve System with Equilibrium Technology and Enfit Enteral ConnectorsCorpak Medsystems · 2014
  • K133599CorgripCorpak Medsystems · 2014
  • K131532Electromagnetic Transmitting StyletCorpak Medsystems · 2013
  • K113351Cortrak Enteral Access DeviceCorpak Medsystems · 20121 Class I recall
  • K100365Farrell Valve with Corflo Anti-IV Connectors Model 20-4300AIVCorpak Medsystems · 2010

Recent decisions in FPD

The FPD category page

  • K243361NutrifitVygon USA · 2024
  • K180236VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)Vr Medical Technology Co., Ltd. · 2019
  • K131590Innersense Esophageal Temperature Probe / Feeding TubePhilips Medical Systems · 2013
  • K120815Innersense Esophageal Temperature/Feeding TubePhilips Medical Systems · 2013
  • K121105Nutrisafe 2 Feeding TubeVygon Corp. · 2012

https://510kreport.com/device/K083786 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083786: Corflo Anti-IV Enteral Feeding Extension Set, Models 20-1006AIV-LB and 20-1030AIV-LB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083786

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026