510(k) · Cleared
ClearedKARL STORZ Trocars with Valve Seals
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz SE & CO. KG · GCJ Laparoscope, General & Plastic Surgery
Cleared on May 11, 2026 as substantially equivalent to K180977 (KARL STORZ Endoscopy-America, Inc., 2018) after a 136-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- May 11, 2026
- Review
- 136 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K940347 (1994). No later device cites it as a predicate yet.
- Root · 2 generations backK940347 Trocars, Cannulae and Sheaths for Endoscopic and Laparoscopic…KARL STORZ Endoscopy-America, Inc. · 1994
- 1 generation backK180977 KARL STORZ New Generation TrocarsKARL STORZ Endoscopy-America, Inc. · 2018
- This deviceK254228 KARL STORZ Trocars with Valve SealsKarl Storz SE & CO. KG · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940347 | Trocars, Cannulae and Sheaths for Endoscopic and Laparoscopic Procedures | KARL STORZ Endoscopy-America, Inc. | 1994 | — |
| −1 | K180977 | KARL STORZ New Generation Trocars | KARL STORZ Endoscopy-America, Inc. | 2018 | — |
| 0 (this device) | K254228 | KARL STORZ Trocars with Valve Seals | Karl Storz SE & CO. KG | 2026 | — |
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 |
|---|---|---|---|
| * | K180977 | KARL STORZ New Generation TrocarsSummary page 5…II Class: Product Code: GCJ Guidance Not applicable Document: Predicate KARL STORZ New Generation Trocars (K180977) Devices: Device The KARL STORZ Trocars with Valve seals provide a port of entry during endoscopic and… | 2018 |
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 32 years and passes through 2 companies; a new generation was cleared every 24.1 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
KARL STORZ Trocars with Valve seals are intended to be used during endoscopic and laparoscopic procedures in general surgery and thoracoscopy in adult and pediatric patients to create and maintain a port of entry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254228 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254228: KARL STORZ Trocars with Valve Seals.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254228
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026