510(k) · Cleared
ClearedNutrifit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Dec 19, 2024 as substantially equivalent to K060944 (Vygon Corp., 2006) after a 51-day review. Its family tree reaches back 2 generations to 1982.
- Decided
- Dec 19, 2024
- Review
- 51 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. No later device cites it as a predicate yet.
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) | K243361 | Nutrifit | Vygon USA | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 5…Product Code(s) FPD, KNT | Legally Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) 21 CFR 807.92(a)(3) Product Code K060944 Nutrisafe 2 FPD Device Description Summary 21 CFR 807.92(a)(4) enteral nutrition and for a short-term use, not longer than 29… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 42 years and passes through 3 companies; a new generation was cleared every 24.6 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 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. 2024, 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 eliminates the risk of IV administration through the feeding tube.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K243361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243361: Nutrifit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243361
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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