510(k) · Cleared
ClearedPrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baylis Medical Technologies, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 28, 2025 as substantially equivalent to K122278 (Baylis Medical Company, Inc., 2012) after a 270-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Oct 28, 2025
- Review
- 270 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K013904 (2002). No later device cites it as a predicate yet.
- Root · 2 generations backK013904 BMC Radio Frequency Perforation Generator, Models RFP-100-115 and…Baylis Medical Co., Inc. · 2002
- 1 generation backK122278 Baylis Medical Company Radiofrequency Perforation GeneratorBaylis Medical Company, Inc. · 2012
- This deviceK250275 PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™…Baylis Medical Technologies, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013904 | BMC Radio Frequency Perforation Generator, Models RFP-100-115 and RFP-100-230 | Baylis Medical Co., Inc. | 2002 | — |
| −1 | K122278 | Baylis Medical Company Radiofrequency Perforation Generator | Baylis Medical Company, Inc. | 2012 | — |
| 0 (this device) | K250275 | PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch | Baylis Medical Technologies, Inc. | 2025 | — |
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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 |
|---|---|---|---|
| * | K122278 | Baylis Medical Company Radiofrequency Perforation GeneratorSummary page 5…fication of Predicate Device The predicate device is the BMC Radiofrequency Puncture Generator & Footswitch, which is cleared under 510(k) Premarket Notification Number K122278 (cleared 07-Nov-2012). This predicate device has not been the subject of a design-related recall. IV. Device Description The P… | 2012 |
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 23 years and passes through 3 companies; a new generation was cleared every 13.0 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K122278.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The PrecisePath Radiofrequency Puncture Generator and Footswitch (optional accessory) is indicated for use in general surgical procedures to cut and coagulate soft tissues.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250275 · printed Nov 5, 2026
Cite this page
510(k) Report. “K250275: PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K250275
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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