510(k) · Cleared
ClearedUniBur
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nakanishi, Inc. · HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Cleared on Sep 19, 2025 as substantially equivalent to K202120 (Nakanishi, Inc., 2021) after a 28-day review. Its family tree reaches back 9 generations to 1993.
- Decided
- Sep 19, 2025
- Review
- 28 days
- Class
- Class II
- Product code
- HBE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K931783 (1993). 49 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 9 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 5 generations between
- 3 generations backK040300 Stryker Consolidated Operating Room Equipment (Core)Stryker Instruments · 2004 · Recalled
- 2 generations backK132264 PRIMADO2 Total Surgical SystemNakanishi, Inc. · 2013
- 1 generation backK202120 P300 AttachmentNakanishi, Inc. · 2021
- This deviceK252662 UniBurNakanishi, Inc. · 2025
Show all 9 generations
- Root · 9 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 8 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 7 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 6 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 5 generations backK991696 Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999
- 4 generations backK032117 Stryker Total Performance (TPS) SystemStryker Instruments · 2003
- 3 generations backK040300 Stryker Consolidated Operating Room Equipment (Core)Stryker Instruments · 2004 · Recalled
- 2 generations backK132264 PRIMADO2 Total Surgical SystemNakanishi, Inc. · 2013
- 1 generation backK202120 P300 AttachmentNakanishi, Inc. · 2021
- This deviceK252662 UniBurNakanishi, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −8 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −7 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −6 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −5 | K991696 | Stryker Hermes-Ready Total Performance System | Stryker Instruments | 1999 | — |
| −4 | K032117 | Stryker Total Performance (TPS) System | Stryker Instruments | 2003 | — |
| −3 | K040300 | Stryker Consolidated Operating Room Equipment (Core) | Stryker Instruments | 2004 | 8 |
| −2 | K132264 | PRIMADO2 Total Surgical System | Nakanishi, Inc. | 2013 | — |
| −1 | K202120 | P300 Attachment | Nakanishi, Inc. | 2021 | — |
| 0 (this device) | K252662 | UniBur | Nakanishi, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 5 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2004 | 4 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 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 HBE? 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 HBE device
- #1 K251433 Surgify Halo (54.085.SHD.H1); Surgify Halo…score 13.1 · 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? (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 |
|---|---|---|---|
| * | K202120 | P300 AttachmentSummary page 5…Accessory/Attachment Predicate Device: Nakanishi P300 Attachment; NSK Sterile Cutting Accessories 510(k) Number: K202120 Product Codes: HBE, ERL, EQJ, HWE, GFF Reference Devices: Medtronic MR8 Drill System, Midas Rex MR8… | 2021 |
| † | K183515 | MR8 Drill System, Midas Rex MR8 ClearView Tools | 2019 |
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 32 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 10 of the 49 ancestors have a recall of any class.
How does its category compare?
All HBE devicesHBE Drills, Burrs, Trephines & Accessories (Simple, Powered): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · HBE
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HBE
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HBE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBE
1,924in 2025
MAUDE reports naming product code HBE, 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 | 2 | — | 0 | 14 |
| 2008 | 2 | — | 47 | 14 |
| 2009 | 0 | — | 7 | 242 |
| 2010 | 0 | — | 23 | 492 |
| 2011 | 2 | — | 1 | 1,013 |
| 2012 | 1 | — | 26 | 1,146 |
| 2013 | 1 | — | 4 | 1,583 |
| 2014 | 2 | — | 0 | 559 |
| 2015 | 3 | 155 | 0 | 483 |
| 2016 | 2 | — | 7 | 848 |
| 2017 | 2 | — | 3 | 848 |
| 2018 | 2 | — | 0 | 787 |
| 2019 | 5 | 133 | 0 | 836 |
| 2020 | 0 | — | 0 | 1,025 |
| 2021 | 6 | 193 | 1 | 1,047 |
| 2022 | 2 | — | 0 | 900 |
| 2023 | 2 | — | 3 | 948 |
| 2024 | 0 | — | 1 | 1,153 |
| 2025 | 6 | 30 | 0 | 1,924 |
| 2026 | 1 | — | 19 | — |
What is it indicated for?
UniBur is for single use only. This device is designed to be used with electric surgical instruments manufactured by Nakanishi INC. This device is intended for: cutting, drilling, removal, and shaping of bones in the fields of Neuro, Spine and ENT surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252662 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252662: UniBur.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252662
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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