510(k) · Cleared
Recalled · 2008Entake Standard and Safety Peg System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmedcorp · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Apr 28, 2006 as substantially equivalent to K924065 (Medical Innovations Corp., 1994) and 1 other predicate after a 15-day review. Its family tree reaches back 3 generations to 2002. 1 later device descends from it. It has been recalled 28 times.
- Decided
- Apr 28, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- KNT
- Recalls
- 28
- Predicates
- 2
Its longest line of descent runs back 3 generations to K014297 (2002). 5 ancestors in all, the oldest K924065 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK014297 Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile…Boston Scientific Corp · 2002
- 2 generations backK030855 Modification to Endovive Initial Placement Peg Kit, Direct Pej Kit…Boston Scientific Corp · 2003 · Recalled
- 1 generation backK031538 Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety KitBoston Scientific Corp · 2003 · Recalled
- This deviceK061021 Entake Standard and Safety Peg SystemConmedcorp · 2006
- Descendant · cites it directly · 0 of its ownK182248 Aspire Venting TubeAspire Bariatrics, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K182248Aspire Venting TubeAspire Bariatrics, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K014297 | Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile Button… | Boston Scientific Corp | 2002 | — |
| −2 | K030855 | Modification to Endovive Initial Placement Peg Kit, Direct Pej Kit, Peg Safety… | Boston Scientific Corp | 2003 | 2 |
| −1 | K031538 | Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety Kit | Boston Scientific Corp | 2003 | 21 |
| 0 (this device) | K061021 | Entake Standard and Safety Peg System | Conmedcorp | 2006 | — |
| +1 | K182248 | Aspire Venting Tube | Aspire Bariatrics, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K924065 | Mic Peg TubeSummary page 1…astrointestinal Tubes and Accessonies 3. Identification of Predicate or Legally Marketed Device: Kimberly-Clark MICTM PEG Standard and Safety Kit, cleared under K924065. Boston Scientific EndoViveflA PEG Standard and Safety Kit, cleared under K03 1538. 4. Device Description The E… | 1994 |
| * | K031538 | Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety KitSummary page 1…Device: Kimberly-Clark MICTM PEG Standard and Safety Kit, cleared under K924065. Boston Scientific EndoViveflA PEG Standard and Safety Kit, cleared under K03 1538. 4. Device Description The EnTake PEG Standard and Safety System contains a gastrostomy feeding tube, external reten… | 2003 |
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 |
|---|---|---|---|
| K182248 | Aspire Venting Tube | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 4, 2008 | Not classified | Z-2187-2009 | Nonconforming Material/Component | The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating… |
| Dec 4, 2008 | Not classified | Z-2186-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2200-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2203-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2183-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2185-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2184-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2205-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2191-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2193-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2194-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2204-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2197-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2206-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2192-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2189-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2181-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2198-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2195-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2180-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2196-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2188-2009 | Nonconforming Material/Component | The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating… |
| Dec 4, 2008 | Not classified | Z-2201-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2207-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2199-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2190-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2182-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2202-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
The 5 latest of 28 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 4 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K182248 (Aspire Bariatrics, Inc., 2018) has gone furthest, with 0 descendants of its own.
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
2007high 16 (2014) · low 4 (2025)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · KNT
136in 2025
2007high 259 (2014) · low 99 (2016)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNT
13in 2025
2007high 82 (2008) · low 0 (2013)2026
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KNT
1,451in 2025
2007high 1,901 (2018) · low 300 (2007)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?
For percutaneous placement of a long-term initial-placement feeding and/or decompression device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061021: Entake Standard and Safety Peg System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061021
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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