510(k) · Cleared
ClearedBaylis Medical Company Radiofrequency Perforation Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baylis Medical Company, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 7, 2012 as substantially equivalent to K013904 (Baylis Medical Co., Inc., 2002) after a 100-day review. Its family tree reaches back 1 generation to 2002. 4 later devices descend from it.
- Decided
- Nov 7, 2012
- Review
- 100 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K013904 (2002). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK013904 BMC Radio Frequency Perforation Generator, Models RFP-100-115 and…Baylis Medical Co., Inc. · 2002
- This deviceK122278 Baylis Medical Company Radiofrequency Perforation GeneratorBaylis Medical Company, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK232809 Cross Vascular RF Generator and Footswitch (optional accessory)Cross Vascular, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK251566 TS-RF Generator (STS10)Starmed Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK250275 PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™…Baylis Medical Technologies, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK252083 HOTWIRE™ System RF Generator and Footswitch (optional accessory)Atraverse Medical, Inc. · 2025
Most influential descendants
Showing 4 of 4 · See all- K232809Cross Vascular RF Generator and Footswitch (optional accessory)Cross Vascular, Inc. · 2023 · cites it directly1descendant
- K251566TS-RF Generator (STS10)Starmed Co., Ltd. · 2025 · cites it directly0descendants
- K250275PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ FootswitchBaylis Medical Technologies, Inc. · 2025 · cites it directly0descendants
- K252083HOTWIRE™ System RF Generator and Footswitch (optional accessory)Atraverse Medical, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013904 | BMC Radio Frequency Perforation Generator, Models RFP-100-115 and RFP-100-230 | Baylis Medical Co., Inc. | 2002 | — |
| 0 (this device) | K122278 | Baylis Medical Company Radiofrequency Perforation Generator | Baylis Medical Company, Inc. | 2012 | — |
| +1 | K232809 | Cross Vascular RF Generator and Footswitch (optional accessory) | Cross Vascular, Inc. | 2023 | — |
| +1 | K251566 | TS-RF Generator (STS10) | Starmed Co., Ltd. | 2025 | — |
| +1 | K250275 | PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch | Baylis Medical Technologies, Inc. | 2025 | — |
| +2 | K252083 | HOTWIRE™ System RF Generator and Footswitch (optional accessory) | Atraverse Medical, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 3 | 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 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 |
|---|---|---|---|
| * | K013904 | BMC Radio Frequency Perforation Generator, Models RFP-100-115 and RFP-100-230Summary page 1…GEl, General and Plastic Surgery Identification of Predicate Device *Device: BMC Radio Frequency Perforation Generator, Model RFP-100 510(k) Number: K(013904 Manufacturer: Baylis Medical Company Inc. Device Description The Baylis Medical Company (BMC) Radiofrequency Perforati… | 2002 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K232809 (Cross Vascular, Inc., 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Baylis Medical Company Radiofrequency Perforation Generator is indicated for use in general surgical procedures to cut and coagulate soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122278 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122278: Baylis Medical Company Radiofrequency Perforation Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122278
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