510(k) · Cleared
Recalled · Class II · 2022YelloPort Elite Port Access System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Innovations Limited · GCJ Laparoscope, General & Plastic Surgery
Cleared on Apr 29, 2019 as substantially equivalent to K070712 (Surgical Innovations Group Plc, 2007) and 1 other predicate after a 53-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Apr 29, 2019
- Review
- 53 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K962193 (1996). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK962193 Portland TrocarsSurgical Innovations Plc · 1996
- 1 generation backK070712 Modification to: Yelloport Port Access SystemSurgical Innovations Group Plc · 2007 · Recalled
- This deviceK190592 YelloPort Elite Port Access SystemSurgical Innovations Limited · 2019
- Descendant · cites it directly · 0 of its ownK210495 Port Access SystemSurgical Innovations Limited · 2021 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K210495Port Access SystemSurgical Innovations Limited · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962193 | Portland Trocars | Surgical Innovations Plc | 1996 | — |
| −1 | K070712 | Modification to: Yelloport Port Access System | Surgical Innovations Group Plc | 2007 | 1 |
| 0 (this device) | K190592 | YelloPort Elite Port Access System | Surgical Innovations Limited | 2019 | — |
| +1 | K210495 | Port Access System | Surgical Innovations Limited | 2021 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (2)
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 |
|---|---|---|---|
| * | K070712 | Modification to: Yelloport Port Access SystemSummary page 6…Primary GCJ GCJ GCJ GCJ Product Code 510(k) N/A K070712 K070712 K032676 Number Environment Hospital Hospital… | 2007 |
| * | K032676 | Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip TrocarSummary page 6…GCJ GCJ GCJ Product Code 510(k) N/A K070712 K070712 K032676 Number Environment Hospital Hospital Hospital Hospital Intended U… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210495 | Port Access System | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 2, 2022 | Class II | Z-1396-2022 | Process change control | There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product. |
| Jan 20, 2022 | Class II | Z-1852-2022 | Process control | Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 12.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K210495 (Surgical Innovations Limited, 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
The YelloPort Elite port access system is indicated for use in laparoscopic procedures to give access to the abdominal cavity while maintaining pneumoperitoneum.
The YelloPort Elite port access system is also indicated for use in laparoscopic procedures to give access to the thoracic cavity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190592 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190592: YelloPort Elite Port Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190592
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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