510(k) · Cleared
Recalled · Class III · 2018Neomed Enteral Only Extension Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neomed, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Aug 3, 2010 as substantially equivalent to K082654 (Respironics, Inc., 2008) after a 183-day review. Its family tree reaches back 3 generations to 1980. 3 later devices descend from it. It has been recalled once.
- Decided
- Aug 3, 2010
- Review
- 183 days
- Class
- Class II
- Product code
- KNT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K801558 (1980). 7 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK801558 Enteric Feeding Tube W/Segm. Flex. WT.Biosearch Medical Products, Inc. · 1980
- 2 generations backK973409 Kangaroo Enteral Feeding Extension Set for Syringe PumpsDavis & Geck, Inc. · 1998
- 1 generation backK082654 Enteral Only Extension SetRespironics, Inc. · 2008
- This deviceK100288 Neomed Enteral Only Extension SetNeomed, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK120272 Ameritus Medical Enteral Feeding Extension SetKentec Medical, Inc. · 2012
- 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
Most influential descendants
Showing 3 of 3 · See all- K120272Ameritus Medical Enteral Feeding Extension SetKentec Medical, Inc. · 2012 · 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K801558 | Enteric Feeding Tube W/Segm. Flex. WT. | Biosearch Medical Products, Inc. | 1980 | — |
| −2 | K973409 | Kangaroo Enteral Feeding Extension Set for Syringe Pumps | Davis & Geck, Inc. | 1998 | — |
| −1 | K082654 | Enteral Only Extension Set | Respironics, Inc. | 2008 | — |
| 0 (this device) | K100288 | Neomed Enteral Only Extension Set | Neomed, Inc. | 2010 | — |
| +1 | K120272 | Ameritus Medical Enteral Feeding Extension Set | Kentec Medical, Inc. | 2012 | — |
| +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 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 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 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 12.8 · 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? (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 |
|---|---|---|---|
| * | K082654 | Enteral Only Extension SetSummary page 1…CLASSIFICATION Gastroenterology/Urology AND PRODUCT Product Code: KNT CODE PREDICATE Respironics Enteral Only Extension Set, K082654 DEVICE NAME SUBSTANTIAL EQUIVALENCE: The NeoMed Enteral Only Extension Set is substantially equivalent to the Respiron… | 2008 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120272 | Ameritus Medical Enteral Feeding Extension Set | 2012 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 24, 2018 | Class III | Z-0526-2019 | Under Investigation by firm | The sterile pouch label states the expiration date is 2016-11-19, but the correct expiration date is 2019-11-09. The case label and the shipper label have the correct date |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 10.7 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K120272 (Kentec Medical, Inc., 2012) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K082654.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 NeoMed Enteral Only 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100288 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100288: Neomed Enteral Only Extension Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100288
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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