510(k) · Cleared
Recalled · Class II · 2018Neomed Polyurethane Feeding Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neomed, Inc. · FPD Tube, Feeding
Cleared on Oct 1, 2008 as substantially equivalent to K072881 (Neomed, Inc., 2008) after a 55-day review. Its family tree reaches back 2 generations to 1995. 4 later devices descend from it. It has been recalled once.
- Decided
- Oct 1, 2008
- Review
- 55 days
- Class
- Class II
- Product code
- FPD
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K945012 (1995). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK945012 Catco Nutritional CatheterCatco Medical, Inc. · 1995
- 1 generation backK072881 NEOMED Enteral FEEDING TUBENeomed, Inc. · 2008
- This deviceK082238 Neomed Polyurethane Feeding TubeNeomed, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK100526 Ameritus Entral (TM) Enteral Feeding TubeKentec Medical, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 1 of its ownK180236 VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)Vr Medical Technology Co., Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK200082 BD Univia RightFit Enteral Extension Sets and Transitional AdaptersMps Medical, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK100366 Medicina Enteral Feeding Tubes and Accessories Model MGX/YYMaxter Catheters · 2010
Most influential descendants
Showing 4 of 4 · See all- K100526Ameritus Entral (TM) Enteral Feeding TubeKentec Medical, Inc. · 2010 · cites it directly2descendants
- K180236VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)Vr Medical Technology Co., Ltd. · 2019 · 2 generations on1descendant
- K200082BD Univia RightFit Enteral Extension Sets and Transitional AdaptersMps Medical, Inc. · 2020 · 3 generations on0descendants
- K100366Medicina Enteral Feeding Tubes and Accessories Model MGX/YYMaxter Catheters · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945012 | Catco Nutritional Catheter | Catco Medical, Inc. | 1995 | — |
| −1 | K072881 | NEOMED Enteral FEEDING TUBE | Neomed, Inc. | 2008 | — |
| 0 (this device) | K082238 | Neomed Polyurethane Feeding Tube | Neomed, Inc. | 2008 | — |
| +1 | K100526 | Ameritus Entral (TM) Enteral Feeding Tube | Kentec Medical, Inc. | 2010 | 9 |
| +2 | K180236 | VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) | Vr Medical Technology Co., Ltd. | 2019 | — |
| +3 | K200082 | BD Univia RightFit Enteral Extension Sets and Transitional Adapters | Mps Medical, Inc. | 2020 | — |
| +1 | K100366 | Medicina Enteral Feeding Tubes and Accessories Model MGX/YY | Maxter Catheters | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K072881 | NEOMED Enteral FEEDING TUBESummary page 1…FR §876.5980 CLASSIFICATION AND PRODUCT Product Code: 78 FPD CODE PREDICATE NeoMed Silicone Enteral Feeding Tube (K072881) DEVICE NAME Cleared January 8, 2008 SUBSTANTIAL EQUIVALENCE: The NeoMed Polyurethane Feeding Tube is subst… | 2008 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 4, 2018 | Class II | Z-0093-2019 | Other | Potential for the tethered plug on the hub of the NeoMed Enteral Feeding Tubes with Enteral Only Connectors to inadvertently open after closure. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 12.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K100526 (Kentec Medical, Inc., 2010) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K072881.
How does its category compare?
All FPD devicesFPD 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
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?
The NeoMed Polyurethane Feeding Tube is intended for nasogastric or orogastric delivery
of various types of liquid nutritional media through the gastro intestinal tract of neonatal and
small pediatric patients, and is not intended for use beyond 30 days.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082238 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082238: Neomed Polyurethane 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/K082238
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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