510(k) · Cleared
ClearedAspire Venting Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aspire Bariatrics, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Nov 13, 2018 as substantially equivalent to K103109 (C.R. Bard, Inc., 2010) and 1 other predicate after an 85-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Nov 13, 2018
- Review
- 85 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K014297 (2002). 8 ancestors in all, the oldest K915837 (1993). No later device cites it as a predicate yet.
- Root · 4 generations backK014297 Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile…Boston Scientific Corp · 2002
- 3 generations backK030855 Modification to Endovive Initial Placement Peg Kit, Direct Pej Kit…Boston Scientific Corp · 2003 · Recalled
- 2 generations backK031538 Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety KitBoston Scientific Corp · 2003 · Recalled
- 1 generation backK061021 Entake Standard and Safety Peg SystemConmedcorp · 2006 · Recalled
- This deviceK182248 Aspire Venting TubeAspire Bariatrics, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K014297 | Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile Button… | Boston Scientific Corp | 2002 | — |
| −3 | K030855 | Modification to Endovive Initial Placement Peg Kit, Direct Pej Kit, Peg Safety… | Boston Scientific Corp | 2003 | 2 |
| −2 | K031538 | Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety Kit | Boston Scientific Corp | 2003 | 21 |
| −1 | K061021 | Entake Standard and Safety Peg System | Conmedcorp | 2006 | 28 |
| 0 (this device) | K182248 | Aspire Venting Tube | Aspire Bariatrics, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 2002 | 1 | 0 |
| 2010 | 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? (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 |
|---|---|---|---|
| * | K103109 | Ponsky* Non-Balloon Replacement Gastrostomy TubeSummary page 4…ct Code: KNT Regulatory Class: II Review Panel: Gastroenterology and Urology Common Name: Gastrostomy tube Predicate Devices: *K103109 Bard Access Systems, Inc., Ponsky Non-Balloon Replacement Gastrostomy Tube (*primary predicate device)… | 2010 |
| * | K061021 | Entake Standard and Safety Peg SystemSummary page 4…evices: *K103109 Bard Access Systems, Inc., Ponsky Non-Balloon Replacement Gastrostomy Tube (*primary predicate device) K061021 ConMed Endoscopic, EnTake PEG Standard Device Description: The Aspire Venting Tube is a gastrostomy tube used to provide sec… | 2006 |
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 16 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 4 of the 8 ancestors have a recall of any class.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Aspire Venting Tube is intended for use in adult patients who require gastric decompression.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182248 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182248: Aspire Venting Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182248
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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