510(k) · Decided
Recalled · Class II · 2017AbbVie PEG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AbbVie, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Jan 14, 2015 as substantially equivalent to K133087 (AbbVie, Inc., 2014) after a 110-day review. Its family tree reaches back 3 generations to 2002. It has been recalled 4 times.
- Decided
- Jan 14, 2015
- Review
- 110 days
- Class
- Class II
- Product code
- KNT
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 3 generations to K014297 (2002). 4 ancestors in all. No later device cites it as a predicate yet.
- 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 backK133087 Abbvie PegAbbVie, Inc. · 2014
- This deviceK142793 AbbVie PEGAbbVie, Inc. · 2015
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 | K133087 | Abbvie Peg | AbbVie, Inc. | 2014 | — |
| 0 (this device) | K142793 | AbbVie PEG | AbbVie, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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? (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 |
|---|---|---|---|
| * | K133087 | Abbvie PegSummary page 4…trointestinal and Accessories (21 CFR 876.5980) Regulatory Class: II Product Code: KNT PREDICATE DEVICE AbbVie PEG, K133087 No reference devices were used in this submission. 08252014-00F9F6… | 2014 |
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 |
|---|---|---|---|---|
| Apr 27, 2017 | Class II | Z-2178-2017 | Under Investigation by firm | PEG kits have the potential for one of the following defects: missing components, duplicate components or missing label/Instructions for Use, which includes expiry information. |
| Apr 27, 2017 | Class II | Z-2176-2017 | Under Investigation by firm | |
| Apr 27, 2017 | Class II | Z-2177-2017 | Under Investigation by firm | PEG kits have the potential for one of the following defects: missing components, duplicate components or missing label/Instructions for Use, which includes expiry information. |
| Nov 22, 2016 | Class II | Z-0786-2017 | Device Design | AbbVie is issuing an urgent field correction notification due to an increased number of reports of disconnections of the AbbVie 20FR PEG tube from the Y-connectors. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- 1 of the 4 ancestors has 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. 2015, 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 AbbVie PEG is intended to provide long-term enteral access for administration of medication to the small intestine when used in conjunction with the AbbVie J, intestinal tube. As needed, enteral nutrition may be administered directly to the stomach in parallel with medication delivery to the intestine. The AbbVie PEG is indicated for the administration of the medication DUOPA (carbidopa and levodopa enteral suspension).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142793 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142793: AbbVie PEG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142793
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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