510(k) · Cleared
ClearedAsc Quadport + 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 Sep 6, 2012 as substantially equivalent to K110004 (Advanced Surgical Concepts, 2011) after a 128-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Sep 6, 2012
- Review
- 128 days
- Class
- Class II
- Product code
- OTJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K010007 (2001). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK010007 Adapt Laparoscopic Port & Adapt Reducer CapTaut, Inc. · 2001 · Recalled
- 5 generations backK070158 R-Port Laparoscopic Access DeviceAdvanced Surgical Concepts · 2007
- 4 generations backK073170 R-Port II Laparoscopic Access DeviceAdvanced Surgical Concepts · 2007
- 3 generations backK073719 Asc Triport Laparoscopic Access DeviceAdvanced Surgical Concepts · 2008
- 2 generations backK101794 Asc Triport Laparoscopic Access Device Model TPRT-02-01 (WA58000T)…Advanced Surgical Concepts · 2010
- 1 generation backK110004 Asc Triport+ Laparoscopic Access DeviceAdvanced Surgical Concepts · 2011
- This deviceK121309 Asc Quadport + Laparoscopic Access DeviceAdvanced Surgical Concepts · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010007 | Adapt Laparoscopic Port & Adapt Reducer Cap | Taut, Inc. | 2001 | 3 |
| −5 | K070158 | R-Port Laparoscopic Access Device | Advanced Surgical Concepts | 2007 | — |
| −4 | K073170 | R-Port II Laparoscopic Access Device | Advanced Surgical Concepts | 2007 | — |
| −3 | K073719 | Asc Triport Laparoscopic Access Device | Advanced Surgical Concepts | 2008 | — |
| −2 | 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 | — |
| 0 (this device) | K121309 | Asc Quadport + Laparoscopic Access Device | 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 |
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 |
|---|---|---|---|
| * | K110004 | Asc Triport+ Laparoscopic Access DeviceSummary page 1…876.1500) Classification Number: Class 11 Product Code: OITJ 8.6 PREDICATE DEVICE ASC TriPort+ Laparoscopic Access Device (K110004) Advanced Surgical Concepts (ASC), Special 510(k) OuadPort+ Laparoscopic Access Device… | 2011 |
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 11 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 2 other devices also cite its predicate K110004.
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. 2012, 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 QuadPort+ 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/K121309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121309: Asc Quadport + 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/K121309
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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