510(k) · Cleared
Recalled · Class II · 2017Nutrisafe 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vygon Corp. · FPD Tube, Feeding
Cleared on Sep 15, 2006 as substantially equivalent to K991918 (Vygon Corp., 1999) and 2 other predicates after a 162-day review. Its family tree reaches back 1 generation to 1982. 1 of the 46 devices in its family, counting itself, has a Class I recall. 42 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 15, 2006
- Review
- 162 days
- Class
- Class II
- Product code
- FPD
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 1 generation to K820176 (1982). 3 ancestors in all. 42 later devices descend from it, 7 citing it directly. 1 of the 46 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK820176 Vygon Enternal Nutrition TubesExco, Inc. · 1982
- This deviceK060944 Nutrisafe 2Vygon Corp. · 2006
- Descendant · cites it directly · 35 of its ownK100099 Oral/Enteral SyringesPhilips Children'S Medical Ventures · 2010
- Descendant · 2 generations on · 33 of its ownK112434 BD Oral/Enteral Syringe with BD Univia ConnectionBd Medical Surgical · 2011
- Descendant · 3 generations on · 31 of its ownK142128 Kangaroo Enteral Feeding Syringes with Enfit ConnectorCovidien · 2015
- Descendant · 4 generations on · 30 of its ownK152857 NeoMed NeoConnect Enteral Syringes with ENFit Connector and…Neomed, Inc. · 2015
- Descendant · 5 generations on · 21 of its ownK161039 NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100…Neomed, Inc. · 2016
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K190502 ENFit Oral / Enteral Syringe6 generations on · 2019
Most influential descendants
Showing 5 of 42 · See all- K100099Oral/Enteral SyringesPhilips Children'S Medical Ventures · 2010 · cites it directly35descendants
- K112434BD Oral/Enteral Syringe with BD Univia ConnectionBd Medical Surgical · 2011 · 2 generations on33descendants
- K142128Kangaroo Enteral Feeding Syringes with Enfit ConnectorCovidien · 2015 · 3 generations on31descendants
- K152857NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip CapsNeomed, Inc. · 2015 · 4 generations on30descendants
- K161039NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect…Neomed, Inc. · 2016 · 5 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K820176 | Vygon Enternal Nutrition Tubes | Exco, Inc. | 1982 | — |
| 0 (this device) | K060944 | Nutrisafe 2 | Vygon Corp. | 2006 | — |
| +1 | K100099 | Oral/Enteral Syringes | Philips Children'S Medical Ventures | 2010 | — |
| +2 | K112434 | BD Oral/Enteral Syringe with BD Univia Connection | Bd Medical Surgical | 2011 | — |
| +3 | K142128 | Kangaroo Enteral Feeding Syringes with Enfit Connector | Covidien | 2015 | — |
| +4 | K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible… | Neomed, Inc. | 2015 | — |
| +5 | K161039 | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and… | Neomed, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 7 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 1 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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 K243361 Nutrifitscore 8.8 · 2 generations · no Class I recall
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K991918 | Nutrisafe Extension TubeSummary page 1…FPD Classification Name: Gastrointestinal tube and accessories devices Classification: Class II Predicate Device Name: Nutrisafe (K991918/ K00331 1), Vygon Enteral Nutrition Tube (K820176) Device Description: The Nutrisafe 2 is a complete system of feedi… | 1999 |
| * | K003311 | Nutrisafe Pur Enteral Feeding TubeSummary page 1…Classification Name: Gastrointestinal tube and accessories devices Classification: Class II Predicate Device Name: Nutrisafe (K991918/ K00331 1), Vygon Enteral Nutrition Tube (K820176) Device Description: The Nutrisafe 2 is a complete system of feeding tubes a… | 2002 |
| * | K820176 | Vygon Enternal Nutrition TubesSummary page 1…testinal tube and accessories devices Classification: Class II Predicate Device Name: Nutrisafe (K991918/ K00331 1), Vygon Enteral Nutrition Tube (K820176) Device Description: The Nutrisafe 2 is a complete system of feeding tubes and accessories. The feeding tube… | 1982 |
What descends from it? (42)
See all 427 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100099 | Oral/Enteral Syringes | 2010 | 35 |
| K100163 | Nutrisafe 2 Feeding Tubes Model 362.XXX. 1362.XXX | 2011 | 1 |
| K243361 | Nutrifit | 2024 | 0 |
| K121105 | Nutrisafe 2 Feeding Tube | 2012 | 0 |
| K120182 | Neomed Gastrointestinal Tube and Accessories | 2012 | 0 |
| K100700 | Med-RX Pediatric Feeding Tubes and Accessories | 2010 | 0 |
| K100366 | Medicina Enteral Feeding Tubes and Accessories Model MGX/YY | 2010 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 24, 2017 | Class II | Z-0678-2018 | Under Investigation by firm | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing… |
| Jan 29, 2010 | Not classified | Z-1204-2010 | Labeling Change Control | Mislabeled feeding syringes : 12 ml syringe mislabeled as 10 ml. |
| Jan 29, 2010 | Not classified | Z-1203-2010 | Labeling Change Control | Mislabeled feeding syringes : 6 ml syringe mislabeled as 5 ml. |
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 · 6 generations on · ◆ in the 2019 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
How does its category compare?
All FPD devicesFPD Tube, Feeding: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FPD
118in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPD
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FPD
10in 2025
MAUDE reports naming product code FPD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 19 |
| 2008 | 4 | 76 | 0 | 24 |
| 2009 | 4 | 69 | 0 | 40 |
| 2010 | 4 | 118 | 0 | 21 |
| 2011 | 2 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 32 |
| 2013 | 2 | — | 0 | 38 |
| 2014 | 0 | — | 0 | 64 |
| 2015 | 0 | — | 1 | 55 |
| 2016 | 0 | — | 0 | 102 |
| 2017 | 0 | — | 0 | 34 |
| 2018 | 0 | — | 3 | 30 |
| 2019 | 1 | — | 1 | 19 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 19 |
| 2023 | 0 | — | 0 | 55 |
| 2024 | 1 | — | 0 | 41 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For nasogastric/oralgastric enteral feeding, incorporating safety connectors which eliminates the risk of IV administration through the feeding tube
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060944 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060944: Nutrisafe 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060944
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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