510(k) · Cleared
ClearedOctotmport
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dalim Surgnet Corporation · OTJ Laparoscopic Single Port Access Device
Cleared on Sep 14, 2011 as substantially equivalent to K100045 (Dalim Surgnet Corporation, 2010) after a 44-day review. Its family tree reaches back 5 generations to 2001. 4 later devices descend from it.
- Decided
- Sep 14, 2011
- Review
- 44 days
- Class
- Class II
- Product code
- OTJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K010007 (2001). 8 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK010007 Adapt Laparoscopic Port & Adapt Reducer CapTaut, Inc. · 2001 · Recalled
- 4 generations backK070158 R-Port Laparoscopic Access DeviceAdvanced Surgical Concepts · 2007
- 3 generations backK073170 R-Port II Laparoscopic Access DeviceAdvanced Surgical Concepts · 2007
- 2 generations backK073719 Asc Triport Laparoscopic Access DeviceAdvanced Surgical Concepts · 2008
- 1 generation backK100045 OCTODalim Surgnet Corporation · 2010
- This deviceK112196 OctotmportDalim Surgnet Corporation · 2011
- Descendant · cites it directly · 3 of its ownK141715 Glove PortNelis · 2015
- Descendant · 2 generations on · 0 of its ownK233263 Disposable TrocarsHangzhou Kangji Medical Instrument Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK220081 Core-SportIncore Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK152598 Endo KeeperNelis · 2016
Most influential descendants
Showing 4 of 4 · See all- K141715Glove PortNelis · 2015 · cites it directly3descendants
- K233263Disposable TrocarsHangzhou Kangji Medical Instrument Co., Ltd. · 2024 · 2 generations on0descendants
- K220081Core-SportIncore Co., Ltd. · 2022 · 2 generations on0descendants
- K152598Endo KeeperNelis · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010007 | Adapt Laparoscopic Port & Adapt Reducer Cap | Taut, Inc. | 2001 | 3 |
| −4 | K070158 | R-Port Laparoscopic Access Device | Advanced Surgical Concepts | 2007 | — |
| −3 | K073170 | R-Port II Laparoscopic Access Device | Advanced Surgical Concepts | 2007 | — |
| −2 | K073719 | Asc Triport Laparoscopic Access Device | Advanced Surgical Concepts | 2008 | — |
| −1 | K100045 | OCTO | Dalim Surgnet Corporation | 2010 | — |
| 0 (this device) | K112196 | Octotmport | Dalim Surgnet Corporation | 2011 | — |
| +1 | K141715 | Glove Port | Nelis | 2015 | — |
| +2 | K233263 | Disposable Trocars | Hangzhou Kangji Medical Instrument Co., Ltd. | 2024 | — |
| +2 | K220081 | Core-Sport | Incore Co., Ltd. | 2022 | — |
| +2 | K152598 | Endo Keeper | Nelis | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K100045 | OCTOSummary page 1…cteristics The purpose of the device modification is to pursue the variety of products for surgeon's preference. Since the submission of the traditional 510(k), K100045, a number of additional non- significant modifications were made to the parent OCTOThI as follow: * The color of the device… | 2010 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141715 | Glove Port | 2015 | 3 |
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 10 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K141715 (Nelis, 2015) has gone furthest, with 3 descendants of its own.
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. 2011, 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 OCTOm Port is intended to use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112196 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112196: Octotmport.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112196
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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