510(k) · Cleared
Recalled · Class II · 2020Ameritus Entral (TM) Enteral Feeding Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kentec Medical, Inc. · FPD Tube, Feeding
Cleared on Apr 22, 2010 as substantially equivalent to K082238 (Neomed, Inc., 2008) and 1 other predicate after a 57-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it. It has been recalled 9 times.
- Decided
- Apr 22, 2010
- Review
- 57 days
- Class
- Class II
- Product code
- FPD
- Recalls
- 9
- Predicates
- 2
Its longest line of descent runs back 3 generations to K945012 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK945012 Catco Nutritional CatheterCatco Medical, Inc. · 1995
- 2 generations backK072881 NEOMED Enteral FEEDING TUBENeomed, Inc. · 2008
- 1 generation backK082238 Neomed Polyurethane Feeding TubeNeomed, Inc. · 2008 · Recalled
- This deviceK100526 Ameritus Entral (TM) Enteral Feeding TubeKentec Medical, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK180236 VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)Vr Medical Technology Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK200082 BD Univia RightFit Enteral Extension Sets and Transitional AdaptersMps Medical, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945012 | Catco Nutritional Catheter | Catco Medical, Inc. | 1995 | — |
| −2 | K072881 | NEOMED Enteral FEEDING TUBE | Neomed, Inc. | 2008 | — |
| −1 | K082238 | Neomed Polyurethane Feeding Tube | Neomed, Inc. | 2008 | 1 |
| 0 (this device) | K100526 | Ameritus Entral (TM) Enteral Feeding Tube | Kentec Medical, Inc. | 2010 | — |
| +1 | K180236 | VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) | Vr Medical Technology Co., Ltd. | 2019 | — |
| +2 | K200082 | BD Univia RightFit Enteral Extension Sets and Transitional Adapters | Mps Medical, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K082238 | Neomed Polyurethane Feeding TubeSummary page 1…VICE CLASSIFICATION Class II per 21 CFR §87 6.5980 PRODUCT CODE FPD PREDICATE DEVICE NeoMed Polyurethane Enteral Feeding Tube (K082238) NAMES NeoMed Silicone Enteral Feeding Tube (K072881) SUBSTANTIAL EQUIVALENCE The Ameritus Entra?~ Fee… | 2008 |
| * | K072881 | NEOMED Enteral FEEDING TUBESummary page 1…FPD PREDICATE DEVICE NeoMed Polyurethane Enteral Feeding Tube (K082238) NAMES NeoMed Silicone Enteral Feeding Tube (K072881) SUBSTANTIAL EQUIVALENCE The Ameritus Entra?~ Feeding Tubes made of either Polyurethane or Silicone are substantially equivalen… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180236 | VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) | 2019 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 17, 2020 | Class II | Z-2515-2020 | Under Investigation by firm | Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient… |
| Jan 17, 2020 | Class II | Z-2520-2020 | Under Investigation by firm | Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient… |
| Jan 17, 2020 | Class II | Z-2519-2020 | Under Investigation by firm | Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient… |
| Jan 17, 2020 | Class II | Z-2518-2020 | Under Investigation by firm | Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient… |
| Jan 17, 2020 | Class II | Z-2514-2020 | Under Investigation by firm | Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient… |
| Jan 17, 2020 | Class II | Z-2516-2020 | Under Investigation by firm | Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient… |
| Jan 17, 2020 | Class II | Z-2517-2020 | Under Investigation by firm | Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient… |
| Jun 23, 2017 | Class II | Z-3073-2017 | Process control | Inadequate detectability of radiopaque stripes |
| Jun 23, 2017 | Class II | Z-3074-2017 | Process control | Inadequate detectability of radiopaque stripes |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K180236 (Vr Medical Technology Co., Ltd., 2019) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K082238.
How does its category compare?
All FPD devicesFPD Tube, Feeding: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Amertius EntralI~ 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/K100526 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100526: Ameritus Entral (TM) 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/K100526
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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