510(k) · Cleared
ClearedStryker Hummer II Microdebrider System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Cleared on Jul 20, 1995 after a 38-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 1,701 devices in its family, counting itself, has a Class I recall. 1,700 later devices descend from it.
- Decided
- Jul 20, 1995
- Review
- 38 days
- Class
- Class II
- Product code
- ERL
- Recalls
- None
- Predicates
- 0
1,700 later devices descend from it, 3 citing it directly. 1 of the 1,701 devices in this family, counting this one, has a Class I recall.
- This deviceK952681 Stryker Hummer II Microdebrider SystemStryker Endoscopy · 1995
- Descendant · cites it directly · 1,219 of its ownK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- Descendant · 2 generations on · 1,073 of its ownK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- Descendant · 3 generations on · 1,069 of its ownK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- Descendant · 4 generations on · 800 of its ownK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- Descendant · 4 generations on · 799 of its ownK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
Showing 5 of 1,700 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub10 generations on · 2021
Most influential descendants
Showing 5 of 1,700 · See all- K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998 · cites it directly1,219descendants
- K981870Visage Cosmetic Surgery SystemArthrocare Corp. · 1998 · 2 generations on1,073descendants
- K000944Thermage Thermacool SystemThermage, Inc. · 2000 · 3 generations on1,069descendants
- K013034Modification to: Thermacool IiaThermage, Inc. · 2001 · 4 generations on800descendants
- K013639Thermage Thermacool TC SystemThermage, Inc. · 2002 · 4 generations on799descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952681 | Stryker Hummer II Microdebrider System | Stryker Endoscopy | 1995 | — |
| +1 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| +2 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| +3 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| +4 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| +4 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 9 | 0 |
| 2002 | 8 | 0 |
| 2003 | 16 | 0 |
| 2004 | 9 | 0 |
| 2005 | 18 | 0 |
| 2006 | 13 | 0 |
| 2007 | 16 | 0 |
| 2008 | 39 | 0 |
| 2009 | 29 | 0 |
| 2010 | 38 | 0 |
| 2011 | 26 | 0 |
| 2012 | 33 | 0 |
| 2013 | 52 | 0 |
| 2014 | 47 | 0 |
| 2015 | 62 | 0 |
| 2016 | 79 | 0 |
| 2017 | 82 | 0 |
| 2018 | 75 | 0 |
| 2019 | 72 | 0 |
| 2020 | 85 | 0 |
| 2021 | 110 | 1 |
| 2022 | 131 | 0 |
| 2023 | 143 | 0 |
| 2024 | 162 | 0 |
| 2025 | 200 | 0 |
| 2026 | 138 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (1,700)
See all 1,7003 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 10 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K973478 (Arthrocare Corp., 1998) has gone furthest, with 1,219 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 | — |
https://510kreport.com/device/K952681 · printed Nov 4, 2026
Cite this page
510(k) Report. “K952681: Stryker Hummer II Microdebrider System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952681
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026