510(k) · Cleared
Recalled · Class III · 2014Laurimed Polypvac Microdebrider
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laurimed, LLC · ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Cleared on Dec 23, 2013 as substantially equivalent to K041413 (Medtronic Xomed, Inc., 2004) after an 84-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it. It has been recalled once.
- Decided
- Dec 23, 2013
- Review
- 84 days
- Class
- Class II
- Product code
- ERL
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002224 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK002224 XPS 3000 SystemMedtronic Xomed · 2000
- 1 generation backK041413 XPS 3000 SystemMedtronic Xomed, Inc. · 2004
- This deviceK133133 Laurimed Polypvac MicrodebriderLaurimed, LLC · 2013
- Descendant · cites it directly · 1 of its ownK161101 PolypVac Microdebrider (3.3mm and 4.0mm)Laurimed, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK163247 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed MicrodebriderLaurimed, LLC · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002224 | XPS 3000 System | Medtronic Xomed | 2000 | — |
| −1 | K041413 | XPS 3000 System | Medtronic Xomed, Inc. | 2004 | — |
| 0 (this device) | K133133 | Laurimed Polypvac Microdebrider | Laurimed, LLC | 2013 | — |
| +1 | K161101 | PolypVac Microdebrider (3.3mm and 4.0mm) | Laurimed, LLC | 2016 | — |
| +2 | K163247 | 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider | Laurimed, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 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 ERL? 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 ERL device
- #1 K243280 Piezomed Pro (Piezomed Pro module M-PM100…score 12.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K041413 | XPS 3000 SystemSummary page 2…Microdebrider F. Predicate Devices The Laurimed PolypVac Microdebrider is substantially equivalent to the Medtronic Xomed, Inc., XPS 3000 System (K041413). G. Device Description The Laurimed PolypVac Microdebrider is intended for cutting and aspirating polyp tissue… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161101 | PolypVac Microdebrider (3.3mm and 4.0mm) | 2016 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 7, 2014 | Class III | Z-1527-2014 | Component design/selection | The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K161101 (Laurimed, LLC, 2016) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K041413.
How does its category compare?
All ERL devicesERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · ERL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ERL
191in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ERL
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ERL
1,469in 2025
MAUDE reports naming product code ERL, 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 | 0 | — | 0 | 112 |
| 2008 | 6 | 181 | 0 | 60 |
| 2009 | 1 | — | 1 | 249 |
| 2010 | 0 | — | 0 | 444 |
| 2011 | 0 | — | 0 | 1,068 |
| 2012 | 2 | — | 0 | 1,379 |
| 2013 | 2 | — | 3 | 3,231 |
| 2014 | 1 | — | 0 | 1,975 |
| 2015 | 3 | 86 | 0 | 2,630 |
| 2016 | 4 | 180 | 0 | 1,455 |
| 2017 | 2 | — | 0 | 999 |
| 2018 | 1 | — | 0 | 1,380 |
| 2019 | 1 | — | 0 | 2,515 |
| 2020 | 1 | — | 5 | 2,369 |
| 2021 | 1 | — | 1 | 2,283 |
| 2022 | 3 | 191 | 0 | 1,574 |
| 2023 | 0 | — | 0 | 1,725 |
| 2024 | 1 | — | 0 | 1,588 |
| 2025 | 1 | — | 0 | 1,469 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Indicated for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133133: Laurimed Polypvac Microdebrider.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133133
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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