510(k) · Cleared
ClearedUnidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz Endoscopy America, Inc. · ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Cleared on Jan 8, 2016 as substantially equivalent to K053262 (KARL STORZ Endoscopy-America, Inc., 2005) after a 270-day review. Its family tree reaches back 1 generation to 2005. 1 later device descends from it.
- Decided
- Jan 8, 2016
- Review
- 270 days
- Class
- Class II
- Product code
- ERL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K053262 (2005). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK053262 Ksea Unidrive Ent/Neuro/Omfs System and AccessoriesKARL STORZ Endoscopy-America, Inc. · 2005
- This deviceK150969 Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II…Karl Storz Endoscopy America, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK200318 UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X…KARL STORZ Endoscopy-America, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K200318UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver HandpieceKARL STORZ Endoscopy-America, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K053262 | Ksea Unidrive Ent/Neuro/Omfs System and Accessories | KARL STORZ Endoscopy-America, Inc. | 2005 | — |
| 0 (this device) | K150969 | Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver… | Karl Storz Endoscopy America, Inc. | 2016 | — |
| +1 | K200318 | UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N… | KARL STORZ Endoscopy-America, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (1)
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 |
|---|---|---|---|
| * | K053262 | Ksea Unidrive Ent/Neuro/Omfs System and AccessoriesSummary page 4…77 (Ear Nose & Throat) 7.3 Substantially Equivalent Predicate Device Device Name: KSEA UNIDRIVE ENT System and Accessories Device 510(k): K053262 7.4 Device Description The UNIDRIVE® S III ENT is a motorized surgical device system, consisting of an active control unit u… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200318 | UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece | 2020 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K200318 (KARL STORZ Endoscopy-America, Inc., 2020) has gone furthest, with 0 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. 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 UNIDRIVE® S I1I ENT system consists of an active control unit used in conjunction with the High-Speed Micro
Motor and DrillCut-X® II Shaver handpiece. The system is intended for use by qualified surgeons to provide controlled
cutting, drilling, debriding, sawing, and shaving for the ablation, excision, removal, or transection of tissue or bone during
head, neck, ENT, or otoneurological 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/K150969 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150969: Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150969
Report an extraction error
Are you the manufacturer?
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