510(k) · Decided
Recalled · Class II · 2023EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · PIF Gastrointestinal Tubes With Enteral Specific Connectors
Cleared on Jun 17, 2016 as substantially equivalent to K910584 (Applied Medical Technologies, 1991) and 2 other predicates after a 67-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it. It has been recalled once.
- Decided
- Jun 17, 2016
- Review
- 67 days
- Class
- Class II
- Product code
- PIF
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K910584 (1991). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK910584 One Step Button (TM)Applied Medical Technologies · 1991 · Recalled
- This deviceK161003 EndoVive One Step Button Low Profile Initial Placement PEG Kit with…Boston Scientific Corporation · 2016
- Descendant · cites it directly · 0 of its ownK191844 Fidmi Low Profile Enteral Feeding DeviceFidmi Medical, Ltd. · 2019
Most influential descendants
Showing 1 of 1 · See all- K191844Fidmi Low Profile Enteral Feeding DeviceFidmi Medical, Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910584 | One Step Button (TM) | Applied Medical Technologies | 1991 | 6 |
| 0 (this device) | K161003 | EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit… | Boston Scientific Corporation | 2016 | — |
| +1 | K191844 | Fidmi Low Profile Enteral Feeding Device | Fidmi Medical, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 PIF? 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 PIF device
- #1 K253715 Edi Catheter ENFit 6Fr/48 cm (6893166); Edi…score 15.5 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K910584 | One Step Button (TM)Summary page 5…Scientific Scientific Scientific Number: Corporation Corporation Corporation Corporation Corporation K910584 K014297 K014297 K014297 K920894 Product Code: KGC KNT… | 1991 |
| * | K014297 | Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile Button Replacement…Summary page 5…Scientific Scientific Number: Corporation Corporation Corporation Corporation Corporation K910584 K014297 K014297 K014297 K920894 Product Code: KGC KNT KNT… | 2002 |
| * | K920894 | Decompression TubesSummary page 5…ion Corporation Corporation Corporation Corporation K910584 K014297 K014297 K014297 K920894 Product Code: KGC KNT KNT KNT KNT Classification Name:… | 1992 |
| † | K150679 | EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial… | 2015 |
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 |
|---|---|---|---|
| K191844 | Fidmi Low Profile Enteral Feeding Device | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2023 | Class II | Z-1153-2024 | Under Investigation by firm | Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the button, which may cause embedding with… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K191844 (Fidmi Medical, Ltd., 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PIF devicesPIF Gastrointestinal Tubes With Enteral Specific Connectors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PIF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PIF
242in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PIF
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PIF
83in 2025
MAUDE reports naming product code PIF, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 3 | 119 | 0 | 0 |
| 2015 | 9 | 143 | 106 | 12 |
| 2016 | 3 | 267 | 0 | 45 |
| 2017 | 5 | 174 | 0 | 17 |
| 2018 | 2 | — | 0 | 17 |
| 2019 | 7 | 135 | 0 | 28 |
| 2020 | 4 | 165 | 0 | 70 |
| 2021 | 4 | 242 | 0 | 89 |
| 2022 | 4 | 167 | 0 | 77 |
| 2023 | 4 | 242 | 0 | 96 |
| 2024 | 2 | — | 1 | 110 |
| 2025 | 2 | — | 0 | 83 |
| 2026 | 3 | 239 | 0 | — |
What is it indicated for?
The One Step Button device is intended to provide nutrition to a patient directly into the stomach through a stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means. The EndoVive Low Profile Replacement Button Gastrostomy device is intended to provide nutrition to a patient directly into the stomach through a stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means.…
Read the full statement (180 words)
The One Step Button device is intended to provide nutrition to a patient directly into the stomach through a stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means.
The EndoVive Low Profile Replacement Button Gastrostomy device is intended to provide nutrition to a patient directly into the stomach through a stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means.
The Right Angle Feeding Set is intended to provide nutrition to a patient directly into the stomach through a gastrostomy tube. It is indicated for use on patients who are unable to consume nutrition by conventional means.
The Bolus Feeding Set is intended to provide nutrition to a patient directly into the stomach through a gastrostomy tube. It is indicated for use on patients who are unable to consume nutrition by conventional means.
The Right Angle Decompression Tube is intended to provide stomach decompression through a gastrostomy tube. It is indicated for use on patients who require enteral feeding as a means of nutritional support
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161003 · printed Nov 4, 2026
Cite this page
510(k) Report. “K161003: EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K161003
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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