510(k) · Cleared
ClearedPolypVac Microdebrider (3.3mm and 4.0mm)
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 Jun 22, 2016 as substantially equivalent to K133133 (Laurimed, LLC, 2013) after a 64-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Jun 22, 2016
- Review
- 64 days
- Class
- Class II
- Product code
- ERL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002224 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK002224 XPS 3000 SystemMedtronic Xomed · 2000
- 2 generations backK041413 XPS 3000 SystemMedtronic Xomed, Inc. · 2004
- 1 generation backK133133 Laurimed Polypvac MicrodebriderLaurimed, LLC · 2013 · Recalled
- This deviceK161101 PolypVac Microdebrider (3.3mm and 4.0mm)Laurimed, LLC · 2016
- Descendant · cites it directly · 0 of its ownK163247 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed MicrodebriderLaurimed, LLC · 2017
Most influential descendants
Showing 1 of 1 · See all- K1632473.3 mm Laurimed Microdebrider; 4.0 mm Laurimed MicrodebriderLaurimed, LLC · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002224 | XPS 3000 System | Medtronic Xomed | 2000 | — |
| −2 | K041413 | XPS 3000 System | Medtronic Xomed, Inc. | 2004 | — |
| −1 | K133133 | Laurimed Polypvac Microdebrider | Laurimed, LLC | 2013 | 1 |
| 0 (this device) | K161101 | PolypVac Microdebrider (3.3mm and 4.0mm) | Laurimed, LLC | 2016 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K133133 | Laurimed Polypvac MicrodebriderSummary page 4…lass II III. Predicate Device [§807.92(a)(3)] The Laurimed PolypVac Microdebrider is substantially equivalent to the Laurimed PolypVac Microdebrider (K133133) CONFIDENTIAL C-2 =… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163247 | 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider | 2017 | 0 |
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 16 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K163247 (Laurimed, LLC, 2017) has gone furthest, with 0 descendants of its own.
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. 2016, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161101: PolypVac Microdebrider (3.3mm and 4.0mm).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161101
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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