510(k) · Cleared
ClearedKeyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport Trucar 8850XX Keyport Trocar 8850XX Sealing CA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · OTJ Laparoscopic Single Port Access Device
Cleared on Aug 3, 2012 as substantially equivalent to K110792 (Applied Medical Resources Corp., 2011) and 4 other predicates after a 130-day review. Its family tree reaches back 8 generations to 1994.
- Decided
- Aug 3, 2012
- Review
- 130 days
- Class
- Class II
- Product code
- OTJ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K940232 (1994). 37 ancestors in all, the oldest K883018 (1988). No later device cites it as a predicate yet.
- Root · 8 generations backK940232 Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc. · 1994
- 7 generations backK961940 Innerdyne Step Trocar Expandable Port, OnestepInnerdyne, Inc. · 1996 · Recalled
- 6 generations backK012539 VerastepUnited States Surgical, A Division of Tyco Healthc · 2001
- 5 generations backK072814 Convenience Kit for Single-Incision Laparoscopic Surgery and Other…Covidien · 2008
- 4 generations backK082619 Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States · 2008
- 3 generations backK093372 Sils Port Model SILSPT15Covidien Lp, Formerly Registered AS Tyco Healthcar · 2009
- 2 generations backK103253 Sils PortCoviden (Formerly Registered AS US Surgical, A Div · 2011
- 1 generation backK110792 Gelpoint PathApplied Medical Resources Corp. · 2011
- This deviceK120898 Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX…Richard Wolf Medical Instruments Corp. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K940232 | Innerdyne Step Trocar Expandable Port, S.T.E.P. | Innerdyne Medical, Inc. | 1994 | — |
| −7 | K961940 | Innerdyne Step Trocar Expandable Port, Onestep | Innerdyne, Inc. | 1996 | 1 |
| −6 | K012539 | Verastep | United States Surgical, A Division of Tyco Healthc | 2001 | — |
| −5 | K072814 | Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced… | Covidien | 2008 | — |
| −4 | K082619 | Sils Port, Models SILSPT5, SILSPT12 | Covidien Lp, Formerly Registered AS United States | 2008 | — |
| −3 | K093372 | Sils Port Model SILSPT15 | Covidien Lp, Formerly Registered AS Tyco Healthcar | 2009 | — |
| −2 | K103253 | Sils Port | Coviden (Formerly Registered AS US Surgical, A Div | 2011 | — |
| −1 | K110792 | Gelpoint Path | Applied Medical Resources Corp. | 2011 | — |
| 0 (this device) | K120898 | Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport… | Richard Wolf Medical Instruments Corp. | 2012 | — |
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 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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? (5)
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 |
|---|---|---|---|
| * | K110792 | Gelpoint PathSummary page 3…or these reasons, the Richard Wolf KeyPort AR~ System is substantially equivalent to the existing 510(k) cleared devices sold by: Applied Medical Resources Corporation (1110792, K090275), Covidien (KI103253), Richard Wolf Medical Instrumnents Corporation (1(000180), and Applied Medical Resources Corporati… | 2011 |
| * | K103253 | Sils PortSummary page 1…etary or model name Manufacturer NumberI I KI 10792 1 Gelpoint Path (Product Code FER) I Applied Medical Resources Corp 2 K103253 2 Sils Port (Product Code GCJ, FER) 2 Covidien (Formerly US Surgical) 3 KO000180 3 TEM Combination… | 2011 |
| * | K000180 | Transanal Endoscopic Microsurgery (Tem) Combination System and Instrument Set…Summary page 1…Code FER) I Applied Medical Resources Corp 2 K103253 2 Sils Port (Product Code GCJ, FER) 2 Covidien (Formerly US Surgical) 3 KO000180 3 TEM Combination System and Instrument Set 3 Richard Wolf Medical Inst. Corp. (Product Code EF… | 2001 |
| * | K090275 | Gelport Single Incision Access SystemSummary page 1…merly US Surgical) 3 KO000180 3 TEM Combination System and Instrument Set 3 Richard Wolf Medical Inst. Corp. (Product Code EFh, GCM)A 4 K090275 4 Gelport Single Incision Access System 4 Applied Medical Resources Corn (1(014047) (Product Code GCJ… | 2009 |
| * | K110004 | Asc Triport+ Laparoscopic Access DeviceSummary page 1…(Product Code EFh, GCM)A 4 K090275 4 Gelport Single Incision Access System 4 Applied Medical Resources Corn (1(014047) (Product Code GCJ) 5 K 110004 5 ASC Triport & Laparoscopic Access Device 5 Advanced Surgical Concepts. (Product Code OTJ, GO… | 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 18 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 37 ancestors have a recall of any class.
- 2 other devices also cite its predicate K110792.
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 KeyPort AR System access device is an endoscopic accessory intended for use as a multiple instrument and/or camera port during minimally invasive anal-rectal procedures such as Transanal Endoscopic Microsurgery (no incision).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120898 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120898: Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport Trucar 8850XX Keyport Trocar 8850XX Sealing CA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120898
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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