510(k) · Cleared
ClearedPassport Robotic Reducer Cap; Passport Stopcock with Rotating Male Luer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · GCJ Laparoscope, General & Plastic Surgery
Cleared on Aug 1, 2013 as substantially equivalent to K080161 (Patton Surgical Corp., 2008) after a 128-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Aug 1, 2013
- Review
- 128 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K901407 (1990). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK901407 Core Disposable TrocarsCore Dynamics, Inc. · 1990
- 2 generations backK992324 Funnel TrocarPatton Medical Corp. · 1999
- 1 generation backK080161 Pasport Optical Trocar, Vortex Seal, Blunt Tip Trocar, Shielded…Patton Surgical Corp. · 2008
- This deviceK130826 Passport Robotic Reducer Cap; Passport Stopcock with Rotating Male…Stryker Endoscopy · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K901407 | Core Disposable Trocars | Core Dynamics, Inc. | 1990 | — |
| −2 | K992324 | Funnel Trocar | Patton Medical Corp. | 1999 | — |
| −1 | K080161 | Pasport Optical Trocar, Vortex Seal, Blunt Tip Trocar, Shielded Trocar… | Patton Surgical Corp. | 2008 | — |
| 0 (this device) | K130826 | Passport Robotic Reducer Cap; Passport Stopcock with Rotating Male Luer | Stryker Endoscopy | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
| 2003 | 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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K080161 | Pasport Optical Trocar, Vortex Seal, Blunt Tip Trocar, Shielded Trocar, Cannula AnchorSummary page 1…GCJ FDA Regulation Number: 21 CFR 876.1500 - Endoscope and accessories Device Classification: Class 11 Premarket Notification: K080161 Device Description The Passport® Trocars with pediatric indication and Accessories (herein referred to as 'proposed de… | 2008 |
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 23 years and passes through 4 companies; a new generation was cleared every 8.8 years on median.
- 1 of the 10 ancestors has a recall of any class.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
Passport® Trocars are indicated for use as access devices that create and maintain a passageway for laparoscopic instruments during a variety of laparoscopic procedures, such as general, gynecologic, thoracic, and urological procedures, in adult and adolescent (12 to 21 years of age) populations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130826 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130826: Passport Robotic Reducer Cap; Passport Stopcock with Rotating Male Luer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130826
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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