510(k) · Cleared
Recalled · Class II · 2015Reprocessed Trocars, Model B5LT and CB5LT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascent Healthcare Solutions · NLM Laparoscope, General & Plastic Surgery, Reprocessed
Cleared on Mar 19, 2010 as substantially equivalent to K062497 (Ascent Healthcare Solutions, 2007) after a 66-day review. Its family tree reaches back 5 generations to 1994. It has been recalled once.
- Decided
- Mar 19, 2010
- Review
- 66 days
- Class
- Class II
- Product code
- NLM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K940232 (1994). 20 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 deviceK100080 Reprocessed Trocars, Model B5LT and CB5LTAscent Healthcare Solutions · 2010
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) | K100080 | Reprocessed Trocars, Model B5LT and CB5LT | Ascent Healthcare Solutions | 2010 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K062497 | Reprocessed TrocarsSummary page 2…applications, patient population, or performance specifications. The information in this traditional 510(k) submission is consistent with the information submitted in K(062497 for Reprocessed Trocars. K(062497 included information for trocars that are limited to one (1) reprocessing cycle. This 510(k) in… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 10, 2015 | Class II | Z-2468-2015 | Labeling mix-ups | Stryker Sustainability Solutions has received reports indicating that devices from one lot (lot# 3574704) were labeled as 100mm models (CB5LT) while the devices inside of the packaging were 75mm models (CB5ST). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 5 of the 20 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. 2010, 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?
Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100080 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100080: Reprocessed Trocars, Model B5LT and CB5LT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100080
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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