510(k) · Cleared
ClearedEndo Keeper
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nelis · OTJ Laparoscopic Single Port Access Device
Cleared on Mar 17, 2016 as substantially equivalent to K141715 (Nelis, 2015) after a 188-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Mar 17, 2016
- Review
- 188 days
- Class
- Class II
- Product code
- OTJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K940232 (1994). 29 ancestors in all, the oldest K883018 (1988). No later device cites it as a predicate yet.
- Root · 7 generations backK940232 Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc. · 1994
- 6 generations backK961940 Innerdyne Step Trocar Expandable Port, OnestepInnerdyne, Inc. · 1996 · Recalled
- 5 generations backK012539 VerastepUnited States Surgical, A Division of Tyco Healthc · 2001
- 4 generations backK072814 Convenience Kit for Single-Incision Laparoscopic Surgery and Other…Covidien · 2008
- 3 generations backK082619 Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States · 2008
- 2 generations backK093372 Sils Port Model SILSPT15Covidien Lp, Formerly Registered AS Tyco Healthcar · 2009
- 1 generation backK141715 Glove PortNelis · 2015
- This deviceK152598 Endo KeeperNelis · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K940232 | Innerdyne Step Trocar Expandable Port, S.T.E.P. | Innerdyne Medical, Inc. | 1994 | — |
| −6 | K961940 | Innerdyne Step Trocar Expandable Port, Onestep | Innerdyne, Inc. | 1996 | 1 |
| −5 | K012539 | Verastep | United States Surgical, A Division of Tyco Healthc | 2001 | — |
| −4 | K072814 | Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced… | Covidien | 2008 | — |
| −3 | K082619 | Sils Port, Models SILSPT5, SILSPT12 | Covidien Lp, Formerly Registered AS United States | 2008 | — |
| −2 | K093372 | Sils Port Model SILSPT15 | Covidien Lp, Formerly Registered AS Tyco Healthcar | 2009 | — |
| −1 | K141715 | Glove Port | Nelis | 2015 | — |
| 0 (this device) | K152598 | Endo Keeper | Nelis | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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 OTJ? 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 OTJ device
- #1 K220081 Core-Sportscore 5.9 · 7 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K141715 | Glove PortSummary page 4…6) Class of device : Class II 7) Panel : General & Plastic Surgery 8) Model type : 20 model codes including X-samll 3. The legally marketed predicate devices : K141715 / Nelis / Glove Port 4. Device description : The Endo Keeper is intended to provide access for multiple instruments and/or en… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 29 ancestors have a recall of any class.
- 2 other devices also cite its predicate K141715.
How does its category compare?
All OTJ devicesOTJ Laparoscopic Single Port Access Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OTJ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OTJ
130in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OTJ
No recall names OTJ since 2007.
Adverse event reports per year · OTJ
1in 2023
MAUDE reports naming product code OTJ, 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 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 2 |
| 2012 | 3 | 130 | 0 | 12 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Endo Keeper is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.
This device is single use and sterilized.
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/K152598 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152598: Endo Keeper.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152598
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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