510(k) · Cleared
ClearedMentor Pathway Introducer/Dilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mentor Corp. · QPB System, Suction, Lipoplasty For Removal
Cleared on Jul 9, 1998 as substantially equivalent to K963760 (Ethicon Endo-Surgery, Inc., 1997) and 3 other predicates after a 72-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Jul 9, 1998
- Review
- 72 days
- Class
- Class II
- Product code
- QPB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K933458 (1994). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK933458 Surgical TrocarsXimed Medical Systems · 1994
- This deviceK981527 Mentor Pathway Introducer/DilatorMentor Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933458 | Surgical Trocars | Ximed Medical Systems | 1994 | — |
| 0 (this device) | K981527 | Mentor Pathway Introducer/Dilator | Mentor Corp. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 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 QPB? 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 QPB device
- #1 K212024 PAL Systemscore 13.7 · 5 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 |
|---|---|---|---|
| * | K963760 | Non-Shielded Surgical Trocar and SleeveSummary page 5…r to devices used to dilate the skin and provide an access port for surgical procedures. Examples of equivalent devices include the Ethicon Non-shielded Surgical Trocar (K963760), the Ximed surgical trocars and cannulae (K933458) and the Applied Medical Technology Endoscopic Access Device (K960232). The Me… | 1997 |
| * | K933458 | Surgical TrocarsSummary page 5…access port for surgical procedures. Examples of equivalent devices include the Ethicon Non-shielded Surgical Trocar (K963760), the Ximed surgical trocars and cannulae (K933458) and the Applied Medical Technology Endoscopic Access Device (K960232). The Mentor Pathway Introducer/Dilator is also similar in… | 1994 |
| * | K960232 | Endoscopic Access DeviceSummary page 5…nclude the Ethicon Non-shielded Surgical Trocar (K963760), the Ximed surgical trocars and cannulae (K933458) and the Applied Medical Technology Endoscopic Access Device (K960232). The Mentor Pathway Introducer/Dilator is also similar in design and intended use to the Lysonix Lipoplasty Access Port (K980763… | 1996 |
| * | K980763 | Lysonix Lipoplasty Access Port Cleared while this submission was under review Summary page 5…al Technology Endoscopic Access Device (K960232). The Mentor Pathway Introducer/Dilator is also similar in design and intended use to the Lysonix Lipoplasty Access Port (K980763). Indications For Use The Mentor Pathway Introducer is indicated for use as an operating port at the skin insertion site when in… | 1998 |
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?
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K963760.
How does its category compare?
All QPB devicesQPB System, Suction, Lipoplasty For Removal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · QPB
5so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QPB
194in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QPB
No recall names QPB since 2007.
Adverse event reports per year · QPB
16in 2025
MAUDE reports naming product code QPB, 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 | 2 | — | 0 | 0 |
| 2008 | 4 | 69 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 3 | 234 | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 3 | 112 | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 28 |
| 2024 | 4 | 194 | 0 | 16 |
| 2025 | 2 | — | 0 | 16 |
| 2026 | 5 | 238 | 0 | — |
What is it indicated for?
The Mentor Pathway Introducer is indicated for use as an operating port at the skin insertion site when instruments are utilized beneath the dermal layer for lipoplasty surgery applications. The Dilator is indicated for dilating the dermal layer and aiding in the insertion of the Pathway Introducer. The Plug is indicated for sealing the lumen of the Pathway Introducer when not in use.
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/K981527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981527: Mentor Pathway Introducer/Dilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981527
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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