510(k) · Cleared
ClearedSkin Level Gastrostomy Tube Kit (Ecsl)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Entracare, LLC · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Aug 31, 2004 as substantially equivalent to K993138 (Ballard Medical Products, 1999) after a 132-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Aug 31, 2004
- Review
- 132 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K922667 (1993). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (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 |
|---|---|---|---|
| * | K993138 | Ballard Mic-Key G Low Profile Gastrostomy Replacement KitSummary page 3…that require a female luer. Equivalent Legally Marketed Device Mic-Key® "G" Low Profile Gastrostomy Tube submitted by Ballard Medical Products Inc., K993138. Performance Standards As of the present time there have been no Performance Standards promulgated for this speci… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K993138.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 ECSL is a low profile balloon gastrostomy tube indicated for use as a replacement tube in an established stoma tract for pediatric, adult and elderly patients who cannot consume an adequate diet orally. Gastrostomy feeding may be indicated for patients with a functioning gut who require long term feeding support. This may include patients for whom malnutrition already exists or may result, secondary to neurological diseases resulting in an…
Read the full statement (109 words)
The ECSL is a low profile balloon gastrostomy tube indicated for use as a replacement tube in an established stoma tract for pediatric, adult and elderly patients who cannot consume an adequate diet orally. Gastrostomy feeding may be indicated for patients with a functioning gut who require long term feeding support. This may include patients for whom malnutrition already exists or may result, secondary to neurological diseases resulting in an abnormality in swallowing; tumors of the head, neck or esophagus; or upper airway diseases or oropharyngeal trauma resulting in an abnormality in swallowing. Some patients who require chronic use of supplemental fluids are also candidates for gastrostomy tube use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041034 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041034: Skin Level Gastrostomy Tube Kit (Ecsl).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041034
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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