510(k) · Cleared
ClearedAmeritus Medical Enteral Feeding Extension Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kentec Medical, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Feb 17, 2012 as substantially equivalent to K100288 (Neomed, Inc., 2010) and 2 other predicates after an 18-day review. Its family tree reaches back 4 generations to 1980. 2 later devices descend from it.
- Decided
- Feb 17, 2012
- Review
- 18 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K801558 (1980). 10 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK801558 Enteric Feeding Tube W/Segm. Flex. WT.Biosearch Medical Products, Inc. · 1980
- 3 generations backK973409 Kangaroo Enteral Feeding Extension Set for Syringe PumpsDavis & Geck, Inc. · 1998
- 2 generations backK082654 Enteral Only Extension SetRespironics, Inc. · 2008
- 1 generation backK100288 Neomed Enteral Only Extension SetNeomed, Inc. · 2010 · Recalled
- This deviceK120272 Ameritus Medical Enteral Feeding Extension SetKentec Medical, Inc. · 2012
- 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 |
|---|---|---|---|---|---|
| −4 | K801558 | Enteric Feeding Tube W/Segm. Flex. WT. | Biosearch Medical Products, Inc. | 1980 | — |
| −3 | K973409 | Kangaroo Enteral Feeding Extension Set for Syringe Pumps | Davis & Geck, Inc. | 1998 | — |
| −2 | K082654 | Enteral Only Extension Set | Respironics, Inc. | 2008 | — |
| −1 | K100288 | Neomed Enteral Only Extension Set | Neomed, Inc. | 2010 | 1 |
| 0 (this device) | K120272 | Ameritus Medical Enteral Feeding Extension Set | Kentec Medical, Inc. | 2012 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1999 | 1 | 0 |
| 2009 | 2 | 0 |
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 KNT? 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 KNT device
- #1 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K100288 | Neomed Enteral Only Extension SetSummary page 1…stinal tubes and accessories Classification Reference: 21 CER 876.5980 Product Code: KNT Predicate Devices: NeoMed Enteral Only Extension Set (K1 00288) CORFLO Anti-l.V. Enteral Feeding Extension Set (K083786)… | 2010 |
| * | K083786 | Corflo Anti-IV Enteral Feeding Extension Set, Models 20-1006AIV-LB and 20-1030AIV-LBSummary page 1…te Devices: NeoMed Enteral Only Extension Set (K1 00288) CORFLO Anti-l.V. Enteral Feeding Extension Set (K083786) CORFLO Anti-I.V. Enteral Feeding Extension Set 20-1060AIV-S (K083791, K… | 2009 |
| * | K083791 | Corflo Anti IV Enteral Feeding Set, Model: 20-1060AIV-SSummary page 1…Extension Set (K083786) CORFLO Anti-I.V. Enteral Feeding Extension Set 20-1060AIV-S (K083791, K083786) Indication for Use: The Enteral Feeding Extension Set (EFES) is intended for use as an extension set for nasogastric!… | 2009 |
| † | K100099 | Oral/Enteral Syringes | 2010 |
| † | K110853 | VR Medical Enteral Oral Syringe | 2011 |
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)
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 32 years and passes through 5 companies; a new generation was cleared every 10.7 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K180236 (Vr Medical Technology Co., Ltd., 2019) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · KNT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNT
136in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNT
13in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KNT
1,451in 2025
MAUDE reports naming product code KNT, 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 | 10 | 118 | 1 | 300 |
| 2008 | 10 | 115 | 82 | 867 |
| 2009 | 11 | 102 | 9 | 818 |
| 2010 | 12 | 104 | 3 | 517 |
| 2011 | 7 | 211 | 2 | 531 |
| 2012 | 12 | 107 | 1 | 528 |
| 2013 | 7 | 128 | 0 | 747 |
| 2014 | 16 | 259 | 0 | 1,030 |
| 2015 | 10 | 140 | 1 | 1,048 |
| 2016 | 6 | 99 | 3 | 1,251 |
| 2017 | 9 | 247 | 4 | 1,672 |
| 2018 | 7 | 149 | 2 | 1,901 |
| 2019 | 10 | 126 | 2 | 1,838 |
| 2020 | 5 | 102 | 1 | 1,641 |
| 2021 | 6 | 121 | 2 | 1,655 |
| 2022 | 7 | 110 | 1 (1) | 1,650 |
| 2023 | 5 | 162 | 2 | 1,863 |
| 2024 | 9 | 103 | 0 | 1,344 |
| 2025 | 4 | 136 | 13 | 1,451 |
| 2026 | 3 | 105 | 20 | — |
What is it indicated for?
The Ameritus® Enteral Feeding Extension Set is intended for use as an extension set for
nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety
connectors which help mitigate the risk of accidental misconnection with an I.V. system
to the enteral system or the enteral system to an I.V. system.
The Enteral Feeding Extension Set is indicated for use in neonatal and pediatnic patients
in connection with an enteral feeding tube to provide nutrition via nasal or oral gastric
placements.
The Enteral Feeding Extension Set is a sterile disposable for single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120272 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120272: Ameritus Medical Enteral Feeding Extension Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120272
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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