510(k) · Cleared
ClearedAsc Triport+ Laparoscopic Access Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Surgical Concepts · OTJ Laparoscopic Single Port Access Device
Cleared on Jan 26, 2011 as substantially equivalent to K101794 (Advanced Surgical Concepts, 2010) after a 23-day review. Its family tree reaches back 5 generations to 2001. 3 later devices descend from it.
- Decided
- Jan 26, 2011
- Review
- 23 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. 3 later devices descend from it, 3 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 backK101794 Asc Triport Laparoscopic Access Device Model TPRT-02-01 (WA58000T)…Advanced Surgical Concepts · 2010
- This deviceK110004 Asc Triport+ Laparoscopic Access DeviceAdvanced Surgical Concepts · 2011
- Descendant · cites it directly · 0 of its ownK121309 Asc Quadport + Laparoscopic Access DeviceAdvanced Surgical Concepts · 2012
- Descendant · cites it directly · 0 of its ownK120898 Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX…Richard Wolf Medical Instruments Corp. · 2012
- Descendant · cites it directly · 0 of its ownK111407 Triport, Triport+, TRIPORT15, QuadportAdvanced Surgical Concepts · 2012
Most influential descendants
Showing 3 of 3 · See all- K121309Asc Quadport + Laparoscopic Access DeviceAdvanced Surgical Concepts · 2012 · cites it directly0descendants
- K120898Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport Trucar 8850XX…Richard Wolf Medical Instruments Corp. · 2012 · cites it directly0descendants
- K111407Triport, Triport+, TRIPORT15, QuadportAdvanced Surgical Concepts · 2012 · cites it directly0descendants
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 | K101794 | Asc Triport Laparoscopic Access Device Model TPRT-02-01 (WA58000T), Asc… | Advanced Surgical Concepts | 2010 | — |
| 0 (this device) | K110004 | Asc Triport+ Laparoscopic Access Device | Advanced Surgical Concepts | 2011 | — |
| +1 | K121309 | Asc Quadport + Laparoscopic Access Device | Advanced Surgical Concepts | 2012 | — |
| +1 | K120898 | Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport… | Richard Wolf Medical Instruments Corp. | 2012 | — |
| +1 | K111407 | Triport, Triport+, TRIPORT15, Quadport | Advanced Surgical Concepts | 2012 | — |
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 |
|---|---|---|
| 2012 | 3 | 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 |
|---|---|---|---|
| * | K101794 | Asc Triport Laparoscopic Access Device Model TPRT-02-01 (WA58000T), Asc Quadport…Summary page 1…essory and Surgical Retractor (21 CFR 876.1500) Classification Number: Class 11 8.6 PREDICATE DEVICE TniPort & QuadPort Laparoscopic Access Devices (K101794) Advanced Surgical Concepts (ASC), 510(k) CONFIDENTIAL TriPort+ Laparoscopic Access Device… | 2010 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 2 companies; a new generation was cleared every 3 months on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K121309 (Advanced Surgical Concepts, 2012) has gone furthest, with 0 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 ASC TriPort+ Laparoscopic Access Device is intended for 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/K110004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110004: Asc Triport+ Laparoscopic Access Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110004
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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