510(k) Report

510(k) · Cleared

Cleared

Nutrisafe Pur Enteral Feeding Tube

K003311510(k) TraditionalCleared Jan 11, 2002445-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

Vygon Corp. · FPD Tube, Feeding

Cleared on Jan 11, 2002 after a 445-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 44 devices in its family, counting itself, has a Class I recall. 43 later devices descend from it.

Decided
Jan 11, 2002
Review
445 days
Class
Class II
Product code
FPD
Recalls
None
Predicates
0

43 later devices descend from it, 1 citing it directly. 1 of the 44 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2006: 1 descendant cleared2010: 3 descendants cleared2012: 2 descendants cleared2024: 1 descendant cleared2011: 3 descendants cleared2015: 2 descendants cleared2014: 1 descendant cleared2016: 7 descendants cleared2017: 4 descendants cleared2026: 2 descendants cleared2018: 3 descendants cleared2020: 3 descendants cleared2021: 4 descendants cleared2019: 2 descendants cleared, 1 with a Class I recall12022: 1 descendant cleared2023: 3 descendants cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK003311 Nutrisafe Pur Enteral Feeding TubeVygon Corp. · 2002
  2. Descendant · cites it directly · 42 of its ownK060944 Nutrisafe 2Vygon Corp. · 2006 · Recalled
  3. Descendant · 2 generations on · 35 of its ownK100099 Oral/Enteral SyringesPhilips Children'S Medical Ventures · 2010
  4. Descendant · 3 generations on · 33 of its ownK112434 BD Oral/Enteral Syringe with BD Univia ConnectionBd Medical Surgical · 2011
  5. Descendant · 4 generations on · 31 of its ownK142128 Kangaroo Enteral Feeding Syringes with Enfit ConnectorCovidien · 2015
  6. Descendant · 5 generations on · 30 of its ownK152857 NeoMed NeoConnect Enteral Syringes with ENFit Connector and…Neomed, Inc. · 2015

Showing 5 of 43 descendants. See all descendants

Descendants cleared per year

2006: 12010: 32011: 32012: 22014: 12015: 22016: 72017: 42018: 32019: 22020: 32021: 42022: 12023: 32024: 12025: 12026: 2
2006high 7 (2016) · low 0 (2007)2026

Class I recalls in this family

  • K190502 ENFit Oral / Enteral Syringe7 generations on · 2019

Most influential descendants

Showing 5 of 43 · See all
  • K060944Nutrisafe 2Vygon Corp. · 2006 · cites it directly42descendants
  • K100099Oral/Enteral SyringesPhilips Children'S Medical Ventures · 2010 · 2 generations on35descendants
  • K112434BD Oral/Enteral Syringe with BD Univia ConnectionBd Medical Surgical · 2011 · 3 generations on33descendants
  • K142128Kangaroo Enteral Feeding Syringes with Enfit ConnectorCovidien · 2015 · 4 generations on31descendants
  • K152857NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip CapsNeomed, Inc. · 2015 · 5 generations on30descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003311Nutrisafe Pur Enteral Feeding TubeVygon Corp.2002—
+1K060944Nutrisafe 2Vygon Corp.20063
+2K100099Oral/Enteral SyringesPhilips Children'S Medical Ventures2010—
+3K112434BD Oral/Enteral Syringe with BD Univia ConnectionBd Medical Surgical2011—
+4K142128Kangaroo Enteral Feeding Syringes with Enfit ConnectorCovidien2015—
+5K152857NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible…Neomed, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201030
201130
201220
201410
201520
201670
201740
201830
201921
202030
202140
202210
202330
202410
202510
202620
FIG. 1 — Lineage of K003311, 2002–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (43)

See all 43

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K060944Nutrisafe 2Vygon Corp.200642

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K190502ENFit Oral / Enteral SyringeJiangsu Caina Medical Co.,Ltd · 2019 · 7 generations on · ◆ in the 2019 descendants bar of FIG. 14 Class I recalls

What does this lineage say?

  • Of its descendants, K060944 (Vygon Corp., 2006) has gone furthest, with 42 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.

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—

More from Vygon Corp.

48 FDA decisions under this applicant name. See the company

  • K121105Nutrisafe 2 Feeding TubeVygon Corp. · 2012
  • K100163Nutrisafe 2 Feeding Tubes Model 362.XXX. 1362.XXXVygon Corp. · 2011
  • K073493Hepatostat SetVygon Corp. · 2008
  • K070705Modification to: Latex-Free Bionector, Model# 896.019, 896.039Vygon Corp. · 200713 recalls
  • K061796Hepatostat Set, Model 760XVygon Corp. · 2006

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/K003311 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003311: Nutrisafe Pur Enteral Feeding Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003311

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026