510(k) · Cleared
ClearedNutrisafe 2 Feeding Tubes Model 362.XXX. 1362.XXX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vygon Corp. · FPD Tube, Feeding
Cleared on Oct 13, 2011 as substantially equivalent to K060944 (Vygon Corp., 2006) after a 631-day review. Its family tree reaches back 2 generations to 1982. 1 later device descends from it.
- Decided
- Oct 13, 2011
- Review
- 631 days
- Class
- Class II
- Product code
- FPD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K820176 (1982). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK820176 Vygon Enternal Nutrition TubesExco, Inc. · 1982
- 1 generation backK060944 Nutrisafe 2Vygon Corp. · 2006 · Recalled
- This deviceK100163 Nutrisafe 2 Feeding Tubes Model 362.XXX. 1362.XXXVygon Corp. · 2011
- Descendant · cites it directly · 0 of its ownK121105 Nutrisafe 2 Feeding TubeVygon Corp. · 2012
Most influential descendants
Showing 1 of 1 · See all- K121105Nutrisafe 2 Feeding TubeVygon Corp. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K820176 | Vygon Enternal Nutrition Tubes | Exco, Inc. | 1982 | — |
| −1 | K060944 | Nutrisafe 2 | Vygon Corp. | 2006 | 3 |
| 0 (this device) | K100163 | Nutrisafe 2 Feeding Tubes Model 362.XXX. 1362.XXX | Vygon Corp. | 2011 | — |
| +1 | K121105 | Nutrisafe 2 Feeding Tube | Vygon Corp. | 2012 | — |
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 |
|---|---|---|
| 2012 | 1 | 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.
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 K243361 Nutrifitscore 8.8 · 2 generations · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K060944 | Nutrisafe 2Summary page 1…Gastrointestinal tube and accessories devices, 21 CFR §876.5980 Regulatory Class: Class 11 Predicate Device: Nutrisafe 2 Feeding Tubes, K060944 Date Prepared: March 15, 2011 Device Description: The Nutrisafe 2 feeding tubes are a product line extension to… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121105 | Nutrisafe 2 Feeding Tube | 2012 | 0 |
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?
- The line of descent spans 29 years and passes through 2 companies; a new generation was cleared every 24.6 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K121105 (Vygon Corp., 2012) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K060944.
How does its category compare?
All FPD devicesFPD Tube, Feeding: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 reduce the risk of misconnections between feeding tubes and intravenous connectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100163 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100163: Nutrisafe 2 Feeding Tubes Model 362.XXX. 1362.XXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100163
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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