510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Corflo Anti IV Enteral Feeding Tube

K083210510(k) TraditionalCleared Dec 29, 200859-day reviewClass II21 CFR 876.5980Recalls 1

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 Dec 29, 2008 after a 59-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 19 later devices descend from it. It has been recalled once.

Decided
Dec 29, 2008
Review
59 days
Class
Class II
Product code
FPD
Recalls
1
Predicates
0

19 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2016: 2 descendants cleared2014: 3 descendants cleared2017: 3 descendants cleared2015: 4 descendants cleared2024: 3 descendants cleared2026: 1 descendant cleared2019: 1 descendant cleared2023: 1 descendant cleared20052010201520202025
  1. This deviceK083210 Corflo Anti IV Enteral Feeding TubeCorpak Medsystems · 2008
  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 · 8 of its ownK112511 Dobbhoff Dual Port Feeding TubeCovidien Lp, Formerly Registered AS Kendall · 2012
  4. Descendant · 2 generations on · 4 of its ownK123555 Kangaroo Feeding Tubes with Iris TechnologyCovidien · 2014
  5. Descendant · 3 generations on · 2 of its ownK142327 smARTrack Feeding Tube SystemArt Healthcare, Ltd. · 2015
  6. Descendant · 4 generations on · 1 of its ownK230206 Entarik Feeding Tube System; Entarik Feeding TubeGravitas Medical, Inc. · 2023

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2012: 12014: 32015: 42016: 22017: 32019: 12023: 12024: 32026: 1
2012high 4 (2015) · low 0 (2013)2026

Most influential descendants

Showing 5 of 19 · See all
  • K140581Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition…Cedic S.R.L. · 2014 · cites it directly8descendants
  • K112511Dobbhoff Dual Port Feeding TubeCovidien Lp, Formerly Registered AS Kendall · 2012 · cites it directly8descendants
  • K123555Kangaroo Feeding Tubes with Iris TechnologyCovidien · 2014 · 2 generations on4descendants
  • K142327smARTrack Feeding Tube SystemArt Healthcare, Ltd. · 2015 · 3 generations on2descendants
  • K230206Entarik Feeding Tube System; Entarik Feeding TubeGravitas Medical, Inc. · 2023 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K083210Corflo Anti IV Enteral Feeding TubeCorpak Medsystems2008—
+1K140581Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit…Cedic S.R.L.2014—
+1K112511Dobbhoff Dual Port Feeding TubeCovidien Lp, Formerly Registered AS Kendall2012—
+2K123555Kangaroo Feeding Tubes with Iris TechnologyCovidien2014—
+3K142327smARTrack Feeding Tube SystemArt Healthcare, Ltd.2015—
+4K230206Entarik Feeding Tube System; Entarik Feeding TubeGravitas Medical, Inc.2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201430
201540
201620
201730
201910
202310
202430
202610
FIG. 1 — Lineage of K083210, 2008–2026Source: 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? (19)

See all 19

3 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
K112511Dobbhoff Dual Port Feeding TubeCovidien Lp, Formerly Registered AS Kendall20128
K151503Nutricare-Isosaf Naso-Gastric Feeding TubeGbuk Enteral Limited20160

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

Recalls of this device

DateClassRecallRoot causeReason
Dec 13, 2017Class IIZ-1277-2018Under Investigation by firmThe transmitting stylet within CORTRAK* 2 nasogastric/Nasointestinal (NG/NI) Feeding Tubes with ANTI-IV* connector (Product Code 20-9551Trak2A) may be visible within the window of the exit port of the feeding tube. Based on…

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. 2008, 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 tube is intended for use in those patients who require intermittent or continuous tube feedings via the nasogastric or nasoenteric route.

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/K083210 · printed Nov 4, 2026

Cite this page

510(k) Report. “K083210: Corflo Anti IV Enteral Feeding Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083210

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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