510(k) · Cleared
ClearedDragonFly Surgical Drill System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grace Medical, Inc. · ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Cleared on Aug 25, 2016 as substantially equivalent to K143492 (Bien-Air Surgery SA, 2015) and 1 other predicate after a 99-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Aug 25, 2016
- Review
- 99 days
- Class
- Class II
- Product code
- ERL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002224 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK002224 XPS 3000 SystemMedtronic Xomed · 2000
- 2 generations backK041523 XPS 3000 SystemMedtronic Xomed, Inc. · 2004
- 1 generation backK143492 OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP…Bien-Air Surgery SA · 2015 · Recalled
- This deviceK161376 DragonFly Surgical Drill SystemGrace Medical, Inc. · 2016
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 | K041523 | XPS 3000 System | Medtronic Xomed, Inc. | 2004 | — |
| −1 | K143492 | OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control… | Bien-Air Surgery SA | 2015 | 2 |
| 0 (this device) | K161376 | DragonFly Surgical Drill System | Grace Medical, Inc. | 2016 | — |
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 |
|---|---|---|---|
| * | K143492 | OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot…Summary page 4…Bur, Ear, Nose and Throat (21 CFR 874.4140, Product Code EQJ), Class I Primary Predicate Device: OSSEOSTAP Microdrill, FDA Clearance K143492 Predicate Device(s): Device Classification Manufacturer Skeeter Ultra-Lite O… | 2015 |
| * | K041523 | XPS 3000 SystemSummary page 4…Classification Manufacturer Skeeter Ultra-Lite Oto-Tool Drill 874.4250, ERL, Class II Medtronic Xomed, Inc. (Accessory of K041523) Drill, Surgical, ENT (electric or pneumatic) including handpiece… | 2004 |
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 16 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K143492.
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?
The DragonFly™ Surgical Drill System has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty.
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/K161376 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161376: DragonFly Surgical Drill System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161376
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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