510(k) · Cleared
ClearedHummer Trak 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 Feb 19, 1999 as substantially equivalent to K952681 (Stryker Endoscopy, 1995) and 1 other predicate after a 44-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Feb 19, 1999
- Review
- 44 days
- Class
- Class II
- Product code
- ERL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K952681 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK952681 Stryker Hummer II Microdebrider SystemStryker Endoscopy · 1995
- This deviceK990038 Hummer Trak SystemStryker Endoscopy · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952681 | Stryker Hummer II Microdebrider System | Stryker Endoscopy | 1995 | — |
| 0 (this device) | K990038 | Hummer Trak System | Stryker Endoscopy | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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? (2)
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 |
|---|---|---|---|
| * | K952681 | Stryker Hummer II Microdebrider SystemSummary page 1…gation. 9. Classification name: dEaii nose, and throat electric or pneumatic surgical ri 10. The Hummer Trak System is equivalent to the Hummer II Microdebrider System (K952681 and K972584). 11. Description: The Hummer Trak System can be sub-divided into two systems, the handpiece and the power unit. The… | 1995 |
| * | K972584 | Stryker Hummer II Microdebrider SystemSummary page 1…lassification name: dEaii nose, and throat electric or pneumatic surgical ri 10. The Hummer Trak System is equivalent to the Hummer II Microdebrider System (K952681 and K972584). 11. Description: The Hummer Trak System can be sub-divided into two systems, the handpiece and the power unit. The power unit… | 1997 |
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 2 ancestors has a recall.
- 2 other devices also cite its predicate K952681.
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?
The device is intended to be utilized during Functional Endoscopic Sinus Surgery (FESS) for the excision of soft and osseous tissues in the sinus cavities.
The device may be utilized for endoscopic or open plastic, reconstructive, and aesthetic surgery of the head and neck.
May be used in conjunction with Visualization Technologies, Inc. (VTI) InstaTrak (K960330) image guided system.
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/K990038 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990038: Hummer Trak System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990038
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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