510(k) · Cleared
ClearedAsc Triport Laparoscopic Access Device Model TPRT-02-01 (WA58000T), Asc Quadport Laparoscopic Asscess Device QPRT-01 (WA
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 Nov 29, 2010 as substantially equivalent to K073719 (Advanced Surgical Concepts, 2008) and 2 other predicates after a 154-day review. Its family tree reaches back 4 generations to 2001. 4 later devices descend from it.
- Decided
- Nov 29, 2010
- Review
- 154 days
- Class
- Class II
- Product code
- OTJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K010007 (2001). 7 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK010007 Adapt Laparoscopic Port & Adapt Reducer CapTaut, Inc. · 2001 · Recalled
- 3 generations backK070158 R-Port Laparoscopic Access DeviceAdvanced Surgical Concepts · 2007
- 2 generations backK073170 R-Port II Laparoscopic Access DeviceAdvanced Surgical Concepts · 2007
- 1 generation backK073719 Asc Triport Laparoscopic Access DeviceAdvanced Surgical Concepts · 2008
- This deviceK101794 Asc Triport Laparoscopic Access Device Model TPRT-02-01 (WA58000T)…Advanced Surgical Concepts · 2010
- Descendant · cites it directly · 3 of its ownK110004 Asc Triport+ Laparoscopic Access DeviceAdvanced Surgical Concepts · 2011
- Descendant · 2 generations on · 0 of its ownK121309 Asc Quadport + Laparoscopic Access DeviceAdvanced Surgical Concepts · 2012
- Descendant · 2 generations on · 0 of its ownK120898 Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX…Richard Wolf Medical Instruments Corp. · 2012
- Descendant · 2 generations on · 0 of its ownK111407 Triport, Triport+, TRIPORT15, QuadportAdvanced Surgical Concepts · 2012
Most influential descendants
Showing 4 of 4 · See all- K110004Asc Triport+ Laparoscopic Access DeviceAdvanced Surgical Concepts · 2011 · cites it directly3descendants
- K121309Asc Quadport + Laparoscopic Access DeviceAdvanced Surgical Concepts · 2012 · 2 generations on0descendants
- K120898Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport Trucar 8850XX…Richard Wolf Medical Instruments Corp. · 2012 · 2 generations on0descendants
- K111407Triport, Triport+, TRIPORT15, QuadportAdvanced Surgical Concepts · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010007 | Adapt Laparoscopic Port & Adapt Reducer Cap | Taut, Inc. | 2001 | 3 |
| −3 | K070158 | R-Port Laparoscopic Access Device | Advanced Surgical Concepts | 2007 | — |
| −2 | K073170 | R-Port II Laparoscopic Access Device | Advanced Surgical Concepts | 2007 | — |
| −1 | K073719 | Asc Triport Laparoscopic Access Device | Advanced Surgical Concepts | 2008 | — |
| 0 (this device) | K101794 | Asc Triport Laparoscopic Access Device Model TPRT-02-01 (WA58000T), Asc… | Advanced Surgical Concepts | 2010 | — |
| +1 | K110004 | Asc Triport+ Laparoscopic Access Device | Advanced Surgical Concepts | 2011 | — |
| +2 | K121309 | Asc Quadport + Laparoscopic Access Device | Advanced Surgical Concepts | 2012 | — |
| +2 | K120898 | Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport… | Richard Wolf Medical Instruments Corp. | 2012 | — |
| +2 | 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 |
|---|---|---|
| 2011 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K073719 | Asc Triport Laparoscopic Access DeviceSummary page 1…ical Retractor (21 CFR 876.1500) Product Code: OTJ 3. PREDICATE DEVICES * TniPort Laparoscopic Access Device subject of K073719 * R-Port 11 Laparoscopic Access Device subject of K073 170 * R-Port Laparoscopic Access Device subject of K070158 4. DEVIC… | 2008 |
| * | K073170 | R-Port II Laparoscopic Access DeviceSummary page 1…) Product Code: OTJ 3. PREDICATE DEVICES * TniPort Laparoscopic Access Device subject of K073719 * R-Port 11 Laparoscopic Access Device subject of K073 170 * R-Port Laparoscopic Access Device subject of K070158 4. DEVICE DESCRIPTION Physical Description Tri~ort Laparoscopi… | 2007 |
| * | K070158 | R-Port Laparoscopic Access DeviceSummary page 1…* TniPort Laparoscopic Access Device subject of K073719 * R-Port 11 Laparoscopic Access Device subject of K073 170 * R-Port Laparoscopic Access Device subject of K070158 4. DEVICE DESCRIPTION Physical Description Tri~ort Laparoscopic Access Device: The modified ASC TniPort Laparoscopic… | 2007 |
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 |
|---|---|---|---|
| K110004 | Asc Triport+ Laparoscopic Access Device | 2011 | 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 9 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K110004 (Advanced Surgical Concepts, 2011) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K073719.
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. 2010, 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 and QuadPort Laparoscopic Access Devices are 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/K101794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101794: Asc Triport Laparoscopic Access Device Model TPRT-02-01 (WA58000T), Asc Quadport Laparoscopic Asscess Device QPRT-01 (WA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101794
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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