510(k) · Cleared
Recalled · 2006Vanguard Reprocessed Bladed Trocar, Non-Bladed Trocar, Trocar Accessories
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 Mar 31, 2005 as substantially equivalent to K012539 (United States Surgical, A Division of Tyco Healthc, 2001) and 4 other predicates after a 92-day review. Its family tree reaches back 3 generations to 1994. 3 later devices descend from it. It has been recalled once.
- Decided
- Mar 31, 2005
- Review
- 92 days
- Class
- Class II
- Product code
- NLM
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 3 generations to K940232 (1994). 10 ancestors in all, the oldest K931337 (1993). 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK940232 Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc. · 1994
- 2 generations backK961940 Innerdyne Step Trocar Expandable Port, OnestepInnerdyne, Inc. · 1996 · Recalled
- 1 generation backK012539 VerastepUnited States Surgical, A Division of Tyco Healthc · 2001
- This deviceK043594 Vanguard Reprocessed Bladed Trocar, Non-Bladed Trocar, Trocar…Vanguard 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 |
|---|---|---|---|---|---|
| −3 | K940232 | Innerdyne Step Trocar Expandable Port, S.T.E.P. | Innerdyne Medical, Inc. | 1994 | — |
| −2 | K961940 | Innerdyne Step Trocar Expandable Port, Onestep | Innerdyne, Inc. | 1996 | 1 |
| −1 | K012539 | Verastep | United States Surgical, A Division of Tyco Healthc | 2001 | — |
| 0 (this device) | K043594 | Vanguard Reprocessed Bladed Trocar, Non-Bladed Trocar, Trocar Accessories | 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 |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1997 | 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? (11)
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 |
|---|---|---|---|
| * | K012539 | VerastepSummary page 1…urgical (AutoSuture) SpringGrip Anchoring Accessory The 5 10(k) Premarket Notification numbers for these devices are: * K012539: VersaStep * K963 115: Trocar Carmula * K954 108: Modified VersaPort… | 2001 |
| * | K963115 | Trocar CannulaSummary page 1…sory The 5 10(k) Premarket Notification numbers for these devices are: * K012539: VersaStep * K963 115: Trocar Carmula * K954 108: Modified VersaPort * K945457: Trocar (Accessory)… | 1997 |
| * | K954108 | Modified VersaportSummary page 1…tification numbers for these devices are: * K012539: VersaStep * K963 115: Trocar Carmula * K954 108: Modified VersaPort * K945457: Trocar (Accessory) * K93 1337: AutoSuture Dila… | 1995 |
| * | K945457 | Trocar ( Accesory)Summary page 1…* K012539: VersaStep * K963 115: Trocar Carmula * K954 108: Modified VersaPort * K945457: Trocar (Accessory) * K93 1337: AutoSuture Dilating Cannula… | 1994 |
| * | K931337 | Auto Suture Dilating CannulaSummary page 1…* K963 115: Trocar Carmula * K954 108: Modified VersaPort * K945457: Trocar (Accessory) * K93 1337: AutoSuture Dilating Cannula… | 1993 |
| * | — | US Surgical (AutoSuture) VersaPort V2 (5-12mm) Trocar System Named without a submission number | |
| * | — | US Surgical (AutoSuture) VersaPort RPF (5-12mm) Trocar System Named without a submission number | |
| * | — | US Surgical (AutoSuture) VersaPort RT (5-12mm) Trocar System Named without a submission number | |
| * | — | US Surgical (AutoSuture) BluntPort (5-12mm) Trocar System Named without a submission number | |
| * | — | US Surgical (AutoSuture) VersaStep (5-12mm) Trocar System Named without a submission number | |
| * | — | US Surgical (AutoSuture) SpringGrip Anchoring Accessory Named without a submission number |
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 |
|---|---|---|---|---|
| Oct 19, 2006 | Not classified | Z-0414-2007 | Process design | The tip of the trocars may separate before and while in use. In some instances the trocars have been found with exposed blades upon opening the packaging. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K062497 (Ascent Healthcare Solutions, 2007) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K012539.
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/K043594 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043594: Vanguard Reprocessed Bladed Trocar, Non-Bladed Trocar, Trocar Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043594
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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