510(k) · Cleared
ClearedSecondary Trocar and Sleeve with Insufflation Port
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pilling Weck Group · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Jan 10, 1997 after a 65-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Jan 10, 1997
- Review
- 65 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK964450 Secondary Trocar and Sleeve with Insufflation PortPilling Weck Group · 1997
- Descendant · cites it directly · 0 of its ownK081398 Advanced Medical Innovations Disposable Trocars and Laparoscopic…Advanced Medical Innovations, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK993653 Micro-France Trocars and AccessoriesXomed, Inc. · 2000
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964450 | Secondary Trocar and Sleeve with Insufflation Port | Pilling Weck Group | 1997 | — |
| +1 | K081398 | Advanced Medical Innovations Disposable Trocars and Laparoscopic Accessories | Advanced Medical Innovations, Inc. | 2009 | — |
| +1 | K993653 | Micro-France Trocars and Accessories | Xomed, Inc. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2009 | 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 HET? 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 HET device
- #1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | — | Core Dynamics Entree II Named without a submission number | |
| * | — | Access Surgical Access Single Use Trocar and Sleeve Named without a submission number | |
| * | — | United States Surgical Acute Suture Surgiport™ Disposable Surgical Trocar and Cannula… Named without a submission number | |
| * | — | Karl Stortz Trocars and Cannula with Insufflation Ports Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K081398 (Advanced Medical Innovations, Inc., 2009) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HET
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HET
269in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HET
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HET
4,513in 2025
MAUDE reports naming product code HET, 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 | 181 |
| 2008 | 3 | 176 | 4 | 359 |
| 2009 | 1 | — | 1 | 403 |
| 2010 | 1 | — | 0 | 214 |
| 2011 | 2 | — | 0 | 417 |
| 2012 | 2 | — | 0 | 1,118 |
| 2013 | 2 | — | 0 | 1,035 |
| 2014 | 0 | — | 0 | 175 |
| 2015 | 2 | — | 1 | 124 |
| 2016 | 0 | — | 0 | 205 |
| 2017 | 2 | — | 0 | 89 |
| 2018 | 1 | — | 0 | 53 |
| 2019 | 2 | — | 0 | 44 |
| 2020 | 2 | — | 0 | 49 |
| 2021 | 4 | 269 | 0 | 132 |
| 2022 | 1 | — | 1 | 216 |
| 2023 | 0 | — | 4 | 824 |
| 2024 | 0 | — | 0 | 3,496 |
| 2025 | 2 | — | 0 | 4,513 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Secondary Trocar and Sleeve with Insufflation Port are manual surgical instruments used to support a cut down(lap approach). The secondary trocar is used in Endoscopic Surgery(Abdominal and Thoracic) for incision and peritoneal access for positioning of the hollow sleeve.
Once the trocar is removed, the port of entry provided by the sleeve, through the cap, is used with manual surgical instruments, endoscopic instruments, laproscopes, and probes. There is an seal on the cap, which closes the port of entry.
The usage of this product is identical to previous devices, which have the same technological characteristics.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964450 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964450: Secondary Trocar and Sleeve with Insufflation Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964450
Report an extraction error
Are you the manufacturer?
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