510(k) · Cleared
ClearedAbbvie 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 Jun 19, 2014 as substantially equivalent to K030855 (Boston Scientific Corp, 2003) after a 262-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.
- Decided
- Jun 19, 2014
- Review
- 262 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K014297 (2002). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK014297 Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile…Boston Scientific Corp · 2002
- 1 generation backK030855 Modification to Endovive Initial Placement Peg Kit, Direct Pej Kit…Boston Scientific Corp · 2003 · Recalled
- This deviceK133087 Abbvie PegAbbVie, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK142793 AbbVie PEGAbbVie, Inc. · 2015 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K142793AbbVie PEGAbbVie, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K014297 | Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile Button… | Boston Scientific Corp | 2002 | — |
| −1 | K030855 | Modification to Endovive Initial Placement Peg Kit, Direct Pej Kit, Peg Safety… | Boston Scientific Corp | 2003 | 2 |
| 0 (this device) | K133087 | Abbvie Peg | AbbVie, Inc. | 2014 | — |
| +1 | K142793 | AbbVie PEG | AbbVie, Inc. | 2015 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K030855 | Modification to Endovive Initial Placement Peg Kit, Direct Pej Kit, Peg Safety KitSummary page 1…estinal and Accessories 21 CFR 876.5980, Product Code KNT, Class 11 Predicate Device: EndoViveTM Initial Placement PEG Kit, K030855 Device Description: The AbbVieTM PEG is a percutaneous endoscopic gastrostomy (PEG or gastric) tube, either IS FR or 20 FR and… | 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 |
|---|---|---|---|
| K142793 | AbbVie PEG | 2015 | 0 |
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 12 years and passes through 2 companies; a new generation was cleared every 11.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K142793 (AbbVie, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K030855.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133087 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133087: Abbvie Peg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133087
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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