510(k) · Cleared
Recalled · 2006Vanguard Reprocessed Dilating Tip and Blunt Trocars
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vanguard Medical Concepts, Inc. · NLM Laparoscope, General & Plastic Surgery, Reprocessed
Cleared on Apr 8, 2005 as substantially equivalent to K020428 (Ethicon Endo-Surgery, Inc., 2002) and 5 other predicates after a 135-day review. Its family tree reaches back 1 generation to 1997. 3 later devices descend from it. It has been recalled once.
- Decided
- Apr 8, 2005
- Review
- 135 days
- Class
- Class II
- Product code
- NLM
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 1 generation to K963760 (1997). 6 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK963760 Non-Shielded Surgical Trocar and SleeveEthicon Endo-Surgery, Inc. · 1997
- This deviceK043253 Vanguard Reprocessed Dilating Tip and Blunt TrocarsVanguard Medical Concepts, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK062497 Reprocessed TrocarsAscent Healthcare Solutions · 2007 · Recalled
- Descendant · 2 generations on · 0 of its ownK132629 Reprocessed Dilating Tip TrocarsStryker Sustainability Solutions · 2013
- Descendant · 2 generations on · 0 of its ownK100080 Reprocessed Trocars, Model B5LT and CB5LTAscent Healthcare Solutions · 2010 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K062497Reprocessed TrocarsAscent Healthcare Solutions · 2007 · cites it directly2descendants
- K132629Reprocessed Dilating Tip TrocarsStryker Sustainability Solutions · 2013 · 2 generations on0descendants
- K100080Reprocessed Trocars, Model B5LT and CB5LTAscent Healthcare Solutions · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963760 | Non-Shielded Surgical Trocar and Sleeve | Ethicon Endo-Surgery, Inc. | 1997 | — |
| 0 (this device) | K043253 | Vanguard Reprocessed Dilating Tip and Blunt Trocars | Vanguard Medical Concepts, Inc. | 2005 | — |
| +1 | K062497 | Reprocessed Trocars | Ascent Healthcare Solutions | 2007 | 2 |
| +2 | K132629 | Reprocessed Dilating Tip Trocars | Stryker Sustainability Solutions | 2013 | — |
| +2 | K100080 | Reprocessed Trocars, Model B5LT and CB5LT | Ascent Healthcare Solutions | 2010 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 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 NLM? 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 NLM device
- #1 K201511 Reprocessed Endoscopic Trocars and Sleevesscore -1.9 · 2 generations · no Class I recall
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K020428 | Endopath Dilating Tip Trocar, Model #512XDSummary page 1…Ethicon® Endopath® Adjustable Stability Thread (5mm-1I2mm) The 5 10(k) Premarket Notification numbers for these devices are: * K020428: EndopathO Dilating Tip Trocar * KOI 1538: Endopath®& Non-Bladed Solid Obturator Trocar System… | 2002 |
| * | K011538 | Endopath Non-Bladed Solid Obturator Trocar System | 2001 |
| * | K011257 | Endopath Non-Bladed Obturator Trocar System (5 MM) | 2001 |
| * | K990028 | Endopath Optiview Optical Surgical Obturator and SleeveSummary page 1…538: Endopath®& Non-Bladed Solid Obturator Trocar System * KOI 1257: EndopathS Non-Bladed Obturator Trocar System (5mm) * K990028: Endopath®M Optiview®&Optical Surgical Obturator and Sleeve * K97 1475: Shielded… | 1999 |
| * | K971475 | Shielded Surgical TrocarSummary page 1…turator Trocar System (5mm) * K990028: Endopath®M Optiview®&Optical Surgical Obturator and Sleeve * K97 1475: Shielded Surgical Trocar * K963760: Non-Shielded Surgical Trocar and Sleeve… | 1997 |
| * | K963760 | Non-Shielded Surgical Trocar and SleeveSummary page 1…: Endopath®M Optiview®&Optical Surgical Obturator and Sleeve * K97 1475: Shielded Surgical Trocar * K963760: Non-Shielded Surgical Trocar and Sleeve Conti… | 1997 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062497 | Reprocessed Trocars | 2007 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 17, 2006 | Not classified | Z-1212-06 | Package design/selection | Review of complaints and testing show that the distal tip of the trocars may separate while in use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All NLM devicesNLM Laparoscope, General & Plastic Surgery, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NLM
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · NLM
284in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NLM
6so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NLM
10in 2025
MAUDE reports naming product code NLM, 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 | 4 | 284 | 0 | 2 |
| 2008 | 0 | — | 1 | 1 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 1 | 11 |
| 2011 | 1 | — | 0 | 7 |
| 2012 | 1 | — | 0 | 82 |
| 2013 | 1 | — | 0 | 102 |
| 2014 | 1 | — | 0 | 84 |
| 2015 | 0 | — | 0 | 27 |
| 2016 | 2 | — | 1 | 39 |
| 2017 | 2 | — | 0 | 15 |
| 2018 | 0 | — | 1 | 9 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 6 | — |
What is it indicated for?
Reprocessed trocars are intended to provide a pathway for entry of instruments during minimally invasive surgery, with particular applications in abdominal, gynecological, urological, and thoracic procedures.
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/K043253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043253: Vanguard Reprocessed Dilating Tip and Blunt Trocars.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043253
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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