510(k) · Cleared
ClearedReprocessed Dilating Tip Trocars
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Sustainability Solutions · NLM Laparoscope, General & Plastic Surgery, Reprocessed
Cleared on Dec 31, 2013 as substantially equivalent to K062497 (Ascent Healthcare Solutions, 2007) and 2 other predicates after a 131-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Dec 31, 2013
- Review
- 131 days
- Class
- Class II
- Product code
- NLM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K940232 (1994). 22 ancestors in all, the oldest K931337 (1993). No later device cites it as a predicate yet.
- Root · 5 generations backK940232 Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc. · 1994
- 4 generations backK961940 Innerdyne Step Trocar Expandable Port, OnestepInnerdyne, Inc. · 1996 · Recalled
- 3 generations backK012539 VerastepUnited States Surgical, A Division of Tyco Healthc · 2001
- 2 generations backK043594 Vanguard Reprocessed Bladed Trocar, Non-Bladed Trocar, Trocar…Vanguard Medical Concepts, Inc. · 2005 · Recalled
- 1 generation backK062497 Reprocessed TrocarsAscent Healthcare Solutions · 2007 · Recalled
- This deviceK132629 Reprocessed Dilating Tip TrocarsStryker Sustainability Solutions · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K940232 | Innerdyne Step Trocar Expandable Port, S.T.E.P. | Innerdyne Medical, Inc. | 1994 | — |
| −4 | K961940 | Innerdyne Step Trocar Expandable Port, Onestep | Innerdyne, Inc. | 1996 | 1 |
| −3 | K012539 | Verastep | United States Surgical, A Division of Tyco Healthc | 2001 | — |
| −2 | K043594 | Vanguard Reprocessed Bladed Trocar, Non-Bladed Trocar, Trocar Accessories | Vanguard Medical Concepts, Inc. | 2005 | 1 |
| −1 | K062497 | Reprocessed Trocars | Ascent Healthcare Solutions | 2007 | 2 |
| 0 (this device) | K132629 | Reprocessed Dilating Tip Trocars | Stryker Sustainability Solutions | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1997 | 3 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 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? (3)
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 |
|---|---|---|---|
| * | K062497 | Reprocessed TrocarsSummary page 1…NLM Citation: 21 CFR §876.1500 Predicate 51 0(k) Title Manufacturer Device K062497 Reprocessed Trocars Stryker Sustainability Solutions K070059 Reprocessed XceI Bladed Tro… | 2007 |
| * | K070059 | Reprocessed TrocarsSummary page 1…51 0(k) Title Manufacturer Device K062497 Reprocessed Trocars Stryker Sustainability Solutions K070059 Reprocessed XceI Bladed Trocars Stryker Sustainability Solutions K12251 1 ENOOPATH XCEL BLADELESS… | 2007 |
| * | K122511 | Endopath Xcel Bladeless Trocar with Optiview Technology Endopath Xcel Blunt Tip Trocar…Summary page 1…Reprocessed Trocars Stryker Sustainability Solutions K070059 Reprocessed XceI Bladed Trocars Stryker Sustainability Solutions K12251 1 ENOOPATH XCEL BLADELESS Ethicon Endo-Surgery TROCAR WITH OPTI VIEW… | 2012 |
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 19 years and passes through 6 companies; a new generation was cleared every 3.6 years on median.
- 5 of the 22 ancestors have a recall of any class.
- 1 other device also cites its predicate K062497.
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. 2013, this device’s year, is highlighted.
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?
The Reprocessed Bladeless Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establsh a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
The Reprocessed Dilating Tip Trocar has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
The Reprocessed Stability Sleeve has application in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132629 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132629: Reprocessed Dilating Tip Trocars.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132629
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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