510(k) · Cleared
ClearedPeleton Universal Single Use Power System and Attachments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Peleton Surgical · SAM Battery-Powered Instruments Charged Through Sterile Barriers
Cleared on Apr 4, 2024 as substantially equivalent to K112599 (Insurgical, LLC, 2012) and 1 other predicate after an 85-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Apr 4, 2024
- Review
- 85 days
- Class
- Class I
- Product code
- SAM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K972367 (1997). No later device cites it as a predicate yet.
- Root · 2 generations backK972367 Stryker System 4000 Heavy Duty Battery Powered EquipmentStryker Instruments · 1997 · Recalled
- 1 generation backK112599 Insurgical Single Use Power EquipmentInsurgical, LLC · 2012
- This deviceK240071 Peleton Universal Single Use Power System and AttachmentsPeleton Surgical · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972367 | Stryker System 4000 Heavy Duty Battery Powered Equipment | Stryker Instruments | 1997 | 10 |
| −1 | K112599 | Insurgical Single Use Power Equipment | Insurgical, LLC | 2012 | — |
| 0 (this device) | K240071 | Peleton Universal Single Use Power System and Attachments | Peleton Surgical | 2024 | — |
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 SAM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K112599 | Insurgical Single Use Power EquipmentSummary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K112599 Insurgical Single Use Power Equipment KIJ K972367… | 2012 |
| * | K972367 | Stryker System 4000 Heavy Duty Battery Powered EquipmentSummary page 5…Product Code K112599 Insurgical Single Use Power Equipment KIJ K972367 STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED KIJ Device Des… | 1997 |
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 27 years and passes through 3 companies; a new generation was cleared every 15.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All SAM devicesSAM Battery-Powered Instruments Charged Through Sterile Barriers: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · SAM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · SAM
Too few SAM 510(k)s in any year since 2007 to give a median.
Recalls per year · SAM
No recall names SAM since 2007.
Adverse event reports per year · SAM
No MAUDE report names SAM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Peleton Surgical Single Use Power Tool System is a battery driven tool system for use in
Trauma, Orthopaedic and Cardio related Surgical Procedures involving drilling, reaming, pin & wire
placement and cutting of bone and hard tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240071 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240071: Peleton Universal Single Use Power System and Attachments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240071
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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