510(k) · Cleared
ClearedhekaDrill
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zethon, Ltd. · HBC Motor, Drill, Electric
Cleared on Apr 9, 2021 as substantially equivalent to K081475 (Medtronic Xomed, Inc., 2008) and 3 other predicates after a 470-day review. Its family tree reaches back 8 generations to 1986.
- Decided
- Apr 9, 2021
- Review
- 470 days
- Class
- Class II
- Product code
- HBC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K862807 (1986). 30 ancestors in all, the oldest K852143 (1985). No later device cites it as a predicate yet.
- Root · 8 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 7 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 6 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 5 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 4 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 3 generations backK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
- 2 generations backK081475 Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System…Medtronic Xomed, Inc. · 2008 · Recalled
- 1 generation backK163565 MR8 Drill SystemMedtronic Powered Surgical Solutions · 2017
- This deviceK193630 hekaDrillZethon, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −7 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −6 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −5 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −4 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −3 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
| −2 | K081475 | Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System… | Medtronic Xomed, Inc. | 2008 | 3 |
| −1 | K163565 | MR8 Drill System | Medtronic Powered Surgical Solutions | 2017 | — |
| 0 (this device) | K193630 | hekaDrill | Zethon, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 HBC? 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 HBC device
- #1 K254174 Surgical Power Systemscore 14.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K081475 | Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Summary page 5…ral surgical procedures. IX. Identification of Legally Marketed Devices (Predicate Devices) x Midas Rex Legend EHS Electric Drill System (K081475) x Midas Rex MR8 Drill System (K163565) x Midas Rex MR7 Pneumatic High Speed System (K090112)… | 2008 |
| * | K163565 | MR8 Drill SystemSummary page 5…of Legally Marketed Devices (Predicate Devices) x Midas Rex Legend EHS Electric Drill System (K081475) x Midas Rex MR8 Drill System (K163565) x Midas Rex MR7 Pneumatic High Speed System (K090112) x Midas Rex Legend System (K020069)… | 2017 |
| * | K090112 | Midas Rex MR7 Pneumatic High Speed System, Models PM700, PM710, PC700, PC710, PC720, PA700Summary page 5…as Rex Legend EHS Electric Drill System (K081475) x Midas Rex MR8 Drill System (K163565) x Midas Rex MR7 Pneumatic High Speed System (K090112) x Midas Rex Legend System (K020069) 510k-001… | 2009 |
| * | K020069 | Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System or Legend…Summary page 5…x Midas Rex MR8 Drill System (K163565) x Midas Rex MR7 Pneumatic High Speed System (K090112) x Midas Rex Legend System (K020069) 510k-001 ,1BHFPG… | 2002 |
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?
- The line of descent spans 35 years and passes through 6 companies; a new generation was cleared every 4.0 years on median.
- 4 of the 30 ancestors have a recall of any class.
- 10 other devices also cite its predicate K081475.
How does its category compare?
All HBC devicesHBC Motor, Drill, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · HBC
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HBC
Too few HBC 510(k)s in any year since 2007 to give a median.
Recalls per year · HBC
9in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBC
635in 2025
MAUDE reports naming product code HBC, 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 | 5 |
| 2008 | 1 | — | 0 | 6 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 9 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 2 | — | 0 | 10,670 |
| 2014 | 1 | — | 1 | 2,643 |
| 2015 | 0 | — | 0 | 1,953 |
| 2016 | 1 | — | 0 | 2,541 |
| 2017 | 2 | — | 0 | 2,079 |
| 2018 | 1 | — | 0 | 1,779 |
| 2019 | 1 | — | 0 | 1,703 |
| 2020 | 0 | — | 0 | 1,304 |
| 2021 | 1 | — | 0 | 946 |
| 2022 | 2 | — | 9 | 760 |
| 2023 | 0 | — | 0 | 663 |
| 2024 | 2 | — | 0 | 427 |
| 2025 | 0 | — | 0 | 635 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The hekaDrill system is intended for use in surgical procedures involving incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone. The system is specifically intended for use in neurologic and general surgical procedures.
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/K193630 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193630: hekaDrill.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193630
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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