510(k) · Cleared
ClearedP300 Attachment
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 Oct 22, 2021 as substantially equivalent to K132264 (Nakanishi, Inc., 2013) after a 449-day review. Its family tree reaches back 8 generations to 1993. 1 later device descends from it.
- Decided
- Oct 22, 2021
- Review
- 449 days
- Class
- Class II
- Product code
- HBE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K931783 (1993). 48 ancestors in all, the oldest K771218 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 7 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 6 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 5 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 4 generations backK991696 Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999
- 3 generations backK032117 Stryker Total Performance (TPS) SystemStryker Instruments · 2003
- 2 generations backK040300 Stryker Consolidated Operating Room Equipment (Core)Stryker Instruments · 2004 · Recalled
- 1 generation backK132264 PRIMADO2 Total Surgical SystemNakanishi, Inc. · 2013
- This deviceK202120 P300 AttachmentNakanishi, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK252662 UniBurNakanishi, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K252662UniBurNakanishi, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −7 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −6 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −5 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −4 | K991696 | Stryker Hermes-Ready Total Performance System | Stryker Instruments | 1999 | — |
| −3 | K032117 | Stryker Total Performance (TPS) System | Stryker Instruments | 2003 | — |
| −2 | K040300 | Stryker Consolidated Operating Room Equipment (Core) | Stryker Instruments | 2004 | 8 |
| −1 | K132264 | PRIMADO2 Total Surgical System | Nakanishi, Inc. | 2013 | — |
| 0 (this device) | K202120 | P300 Attachment | Nakanishi, Inc. | 2021 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 13.2 · 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 |
|---|---|---|---|
| * | K132264 | PRIMADO2 Total Surgical SystemSummary page 5…GFF 878.4820 Bur, Surgical, General & Plastic Surgery Predicate Device: Nakanishi Primado2 Total Surgical System 510(k) Number: K132264 Product Codes: HBC, ERL Product Codes for Accessories: DZI, DZJ, ERL, GEY, HBC, HBE… | 2013 |
| † | K143540 | Stryker MIS Attachments and Cutting Accessories | 2015 |
| † | K143320 | Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments | 2015 |
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 |
|---|---|---|---|
| K252662 | UniBur | 2025 | 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?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 10 of the 48 ancestors have a recall of any class.
- Of its descendants, K252662 (Nakanishi, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K132264.
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. 2021, 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?
The P300 Attachment is intended to be used with electric and pneumatic surgical instruments and cutting accessories for cutting, drilling, removal, and shaping of bone in the procedures of: Neuro, Spine, Orthopedic, ENT, Maxillofacial, and General Surgery.
NSK Sterile Cutting Accessory(ies) is for single use only. This device is intended for use, in conjunction with P300 Attachment, in cutting, drilling, removal, and shaping of bone in the procedures of: Neuro, Spine, Orthopedic, ENT, Maxillofacial, and General Surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202120 · printed Nov 4, 2026
Cite this page
510(k) Report. “K202120: P300 Attachment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K202120
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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