510(k) · Cleared
Recalled · Class II · 2019Med-RX Pediatric Feeding Tubes and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Benlan, Inc. · FPD Tube, Feeding
Cleared on Dec 13, 2010 as substantially equivalent to K060944 (Vygon Corp., 2006) and 1 other predicate after a 276-day review. Its family tree reaches back 6 generations to 1981. It has been recalled 6 times.
- Decided
- Dec 13, 2010
- Review
- 276 days
- Class
- Class II
- Product code
- FPD
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 6 generations to K810156 (1981). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK810156 Argyle Salem Sump TubeSherwood Medical Co. · 1981 · Recalled
- 5 generations backK971354 Knott NG TubeMichael M. Knott, M.D. · 1997
- 4 generations backK020005 Infant Feeding TubesPromedic, Inc. · 2002
- 3 generations backK052903 Pediatric Feeding TubePromedic, Inc. · 2005
- 2 generations backK072756 Non-IV Adapter for Infant NG TubePromedic, Inc. · 2007
- 1 generation backK082710 Safechild Enteral Feeding Tube and Accessories and Feeding Tube…Neochild, LLC · 2009
- This deviceK100700 Med-RX Pediatric Feeding Tubes and AccessoriesBenlan, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K810156 | Argyle Salem Sump Tube | Sherwood Medical Co. | 1981 | 3 |
| −5 | K971354 | Knott NG Tube | Michael M. Knott, M.D. | 1997 | — |
| −4 | K020005 | Infant Feeding Tubes | Promedic, Inc. | 2002 | — |
| −3 | K052903 | Pediatric Feeding Tube | Promedic, Inc. | 2005 | — |
| −2 | K072756 | Non-IV Adapter for Infant NG Tube | Promedic, Inc. | 2007 | — |
| −1 | K082710 | Safechild Enteral Feeding Tube and Accessories and Feeding Tube Extension Set | Neochild, LLC | 2009 | — |
| 0 (this device) | K100700 | Med-RX Pediatric Feeding Tubes and Accessories | Benlan, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K060944 | Nutrisafe 2Summary page 2…is substantially equivalent to legally marketed devices. The proposed MED-RX Pediatric Feeding Tube and Accessories is substantalIly equivalent to the Vygon Nutrisafe 2 (K060944) and the NeoChild SafeChild Infant Feeding Tubes and Accessories (K082710). Both the proposed and the predicate devices have the… | 2006 |
| * | K082710 | Safechild Enteral Feeding Tube and Accessories and Feeding Tube Extension SetSummary page 1…Class 11 Product Code: FPD Predicate Devices: Vygon Nutrisafe 2 (K(060944) NeoChild SafeChild Infant Feeding Tube and Accessories (K082710) Device Description The MED-RX Pediatric Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as di… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 22, 2019 | Class II | Z-2293-2019 | Nonconforming Material/Component | Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector has detached from the feeding tube. |
| Jul 16, 2019 | Class II | Z-2281-2019 | Under Investigation by firm | The firm received a complaint that the connector detached from the feeding tube. |
| Dec 17, 2018 | Class II | Z-0746-2019 | Under Investigation by firm | Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes. |
| Dec 1, 2018 | Class II | Z-0725-2019 | Under Investigation by firm | The product may be packaged with a 5FR X 24 length Feeding tube instead of a 6.5 FR X 24 Feeding tube as labeled. |
| Jun 11, 2018 | Class II | Z-2440-2018 | Process control | The product may be packaged with the incorrect length of feeding tube as labeled. |
| Dec 11, 2015 | Class II | Z-0595-2016 | Under Investigation by firm | The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size. |
The 5 latest of 6 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 29 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 3 of the 14 ancestors have a recall of any class.
- 6 other devices also cite its predicate K060944.
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 MED-RX Pediatric Feeding Tube and Accessories are disposable, single use enteral feeding devices featuring non-luer enteral only connectors. The MED-RX Pediatric Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding, as directed by a physician. The MED-RX Enteral Extension Set is an accessory to the MED-RX Pediatric Feeding Tube, to be used to deliver fluids from the nutritional source to an existing non-luer pediatric feeding tube. The MED-RX Pediatric Feeding Tube and Accessories are for hospital use, pediatric patient use only, and are not intended for use beyond 30 days.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100700 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100700: Med-RX Pediatric Feeding Tubes and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100700
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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