510(k) · Cleared
ClearedPromex Ent Tissue Removal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Promex, Inc. · ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Cleared on Sep 29, 1997 after a 56-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Sep 29, 1997
- Review
- 56 days
- Class
- Class II
- Product code
- ERL
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK972865 Promex Ent Tissue Removal SystemPromex, Inc. · 1997
- Descendant · cites it directly · 4 of its ownK161307 NICO MyriadNico Corporation · 2016
- Descendant · 2 generations on · 1 of its ownK182340 NICO MyriadNico Corporation · 2018
- Descendant · 2 generations on · 1 of its ownK180372 Aurora EvacuatorRebound Therapeutics · 2018
- Descendant · 3 generations on · 0 of its ownK191599 NICO Myriad NOVUSNico Corporation · 2019 · Recalled
- Descendant · 3 generations on · 0 of its ownK190075 Aurora EvacuatorRebound Therapeutics · 2019
Most influential descendants
Showing 5 of 5 · See all- K161307NICO MyriadNico Corporation · 2016 · cites it directly4descendants
- K182340NICO MyriadNico Corporation · 2018 · 2 generations on1descendant
- K180372Aurora EvacuatorRebound Therapeutics · 2018 · 2 generations on1descendant
- K191599NICO Myriad NOVUSNico Corporation · 2019 · 3 generations on0descendants
- K190075Aurora EvacuatorRebound Therapeutics · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972865 | Promex Ent Tissue Removal System | Promex, Inc. | 1997 | — |
| +1 | K161307 | NICO Myriad | Nico Corporation | 2016 | — |
| +2 | K182340 | NICO Myriad | Nico Corporation | 2018 | — |
| +2 | K180372 | Aurora Evacuator | Rebound Therapeutics | 2018 | — |
| +3 | K191599 | NICO Myriad NOVUS | Nico Corporation | 2019 | 5 |
| +3 | K190075 | Aurora Evacuator | Rebound Therapeutics | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161307 | NICO Myriad | 2016 | 4 |
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?
- Of its descendants, K161307 (Nico Corporation, 2016) has gone furthest, with 4 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.
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?
For the removal of soft tissue and bone in the ear, nose & throat.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972865 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972865: Promex Ent Tissue Removal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972865
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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