510(k) · Cleared
Recalled · Class II · 2015One Step Button (TM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Technologies · KGC Tube, Gastro-Enterostomy
Cleared on May 23, 1991 after a 101-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled 6 times.
- Decided
- May 23, 1991
- Review
- 101 days
- Class
- Class II
- Product code
- KGC
- Recalls
- 6
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK910584 One Step Button (TM)Applied Medical Technologies · 1991
- Descendant · cites it directly · 1 of its ownK161003 EndoVive One Step Button Low Profile Initial Placement PEG Kit with…Boston Scientific Corporation · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK191844 Fidmi Low Profile Enteral Feeding DeviceFidmi Medical, Ltd. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910584 | One Step Button (TM) | Applied Medical Technologies | 1991 | — |
| +1 | K161003 | EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit… | Boston Scientific Corporation | 2016 | 1 |
| +2 | K191844 | Fidmi Low Profile Enteral Feeding Device | Fidmi Medical, Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KGC? 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 KGC device
- #1 K242211 PUMA-G Pediatric Systemscore 10.5 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161003 | EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector… | 2016 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 11, 2015 | Class II | Z-0402-2016 | Under Investigation by firm | Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Button, including the Decompression Tube and Low Profile Replacement Button devices because they may contain decompression tube adapters with a… |
| Jun 2, 2005 | Not classified | Z-0962-05 | Other | Two blades may be heat staked onto the stiletto instead of the expected one blade. |
| Jun 2, 2005 | Not classified | Z-0969-05 | Other | Two blades may be heat staked onto the stiletto instead of the expected one blade. |
| Jun 2, 2005 | Not classified | Z-0972-05 | Other | Two blades may be heat staked onto the stiletto instead of the expected one blade. |
| Jun 2, 2005 | Not classified | Z-0970-05 | Other | Two blades may be heat staked onto the stiletto instead of the expected one blade. |
| Jun 2, 2005 | Not classified | Z-0971-05 | Other | Two blades may be heat staked onto the stiletto instead of the expected one blade. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K161003 (Boston Scientific Corporation, 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KGC devicesKGC Tube, Gastro-Enterostomy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KGC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGC
159in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGC
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGC
106in 2025
MAUDE reports naming product code KGC, 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 | 12 |
| 2008 | 2 | — | 0 | 30 |
| 2009 | 1 | — | 5 | 47 |
| 2010 | 0 | — | 6 | 67 |
| 2011 | 0 | — | 0 | 36 |
| 2012 | 1 | — | 0 | 16 |
| 2013 | 0 | — | 0 | 17 |
| 2014 | 0 | — | 0 | 41 |
| 2015 | 0 | — | 1 | 72 |
| 2016 | 0 | — | 0 | 69 |
| 2017 | 1 | — | 0 | 102 |
| 2018 | 0 | — | 0 | 84 |
| 2019 | 3 | 159 | 0 | 90 |
| 2020 | 1 | — | 0 | 118 |
| 2021 | 0 | — | 0 | 73 |
| 2022 | 0 | — | 0 | 51 |
| 2023 | 1 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 87 |
| 2025 | 1 | — | 0 | 106 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K910584 · printed Nov 6, 2026
Cite this page
510(k) Report. “K910584: One Step Button (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910584
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026