510(k) · Cleared
ClearedVR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vr Medical Technology Co., Ltd. · FPD Tube, Feeding
Cleared on Jan 18, 2019 as substantially equivalent to K100526 (Kentec Medical, Inc., 2010) and 2 other predicates after a 354-day review. Its family tree reaches back 5 generations to 1980. 1 later device descends from it.
- Decided
- Jan 18, 2019
- Review
- 354 days
- Class
- Class II
- Product code
- FPD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K801558 (1980). 18 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK801558 Enteric Feeding Tube W/Segm. Flex. WT.Biosearch Medical Products, Inc. · 1980
- 4 generations backK973409 Kangaroo Enteral Feeding Extension Set for Syringe PumpsDavis & Geck, Inc. · 1998
- 3 generations backK082654 Enteral Only Extension SetRespironics, Inc. · 2008
- 2 generations backK100288 Neomed Enteral Only Extension SetNeomed, Inc. · 2010 · Recalled
- 1 generation backK120272 Ameritus Medical Enteral Feeding Extension SetKentec Medical, Inc. · 2012
- This deviceK180236 VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)Vr Medical Technology Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK200082 BD Univia RightFit Enteral Extension Sets and Transitional AdaptersMps Medical, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K200082BD Univia RightFit Enteral Extension Sets and Transitional AdaptersMps Medical, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K801558 | Enteric Feeding Tube W/Segm. Flex. WT. | Biosearch Medical Products, Inc. | 1980 | — |
| −4 | K973409 | Kangaroo Enteral Feeding Extension Set for Syringe Pumps | Davis & Geck, Inc. | 1998 | — |
| −3 | K082654 | Enteral Only Extension Set | Respironics, Inc. | 2008 | — |
| −2 | K100288 | Neomed Enteral Only Extension Set | Neomed, Inc. | 2010 | 1 |
| −1 | K120272 | Ameritus Medical Enteral Feeding Extension Set | Kentec Medical, Inc. | 2012 | — |
| 0 (this device) | K180236 | VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) | Vr Medical Technology Co., Ltd. | 2019 | — |
| +1 | 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 | 3 | 0 |
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K100526 | Ameritus Entral (TM) Enteral Feeding TubeSummary page 4…21CFR 876.5980 FPD, KNT, PIF Class II Predicate Devices: K100526 – Kentec Enteral Feeding Tube K150084 – Covidien Argyle PVC Enteral Feeding Tubes… | 2010 |
| * | K150084 | Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric…Summary page 4…Class II Predicate Devices: K100526 – Kentec Enteral Feeding Tube K150084 – Covidien Argyle PVC Enteral Feeding Tubes K120272 – Kentec Enteral Feeding Tube Exten… | 2015 |
| * | K120272 | Ameritus Medical Enteral Feeding Extension SetSummary page 4…526 – Kentec Enteral Feeding Tube K150084 – Covidien Argyle PVC Enteral Feeding Tubes K120272 – Kentec Enteral Feeding Tube Extension Sets Device Description: Enteral Feeding Tube The VR Medical Feeding Tube is intended fo… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200082 | BD Univia RightFit Enteral Extension Sets and Transitional Adapters | 2020 | 0 |
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 39 years and passes through 6 companies; a new generation was cleared every 6.9 years on median.
- 5 of the 18 ancestors have a recall of any class.
- Of its descendants, K200082 (Mps Medical, Inc., 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FPD devicesFPD Tube, Feeding: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 VR Medical 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. The Enteral Feeding Extension Set (EFES) is intended for use as an extension set for nasogastric / oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors/small bore connectors which…
Read the full statement (112 words)
The VR Medical 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.
The Enteral Feeding Extension Set (EFES) is intended for use as an extension set for nasogastric / oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors/small bore connectors which are intended to reduce the misconnection between the following applications: I.V. system and Enteral Feeding System.
The EFES is indicated for use in neonatal and pediatric patients in connection with an enteral feeding tube to provide nutrition via nasal or oral gastric placements.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180236: VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180236
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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