510(k) · Cleared
ClearedPain Management Optima, Model PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baylis Medical Co., Inc. · GXI Probe, Radiofrequency Lesion
Cleared on Oct 16, 2009 as substantially equivalent to K972846 (Baylis Medical Co., Inc., 1998) after a 73-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.
- Decided
- Oct 16, 2009
- Review
- 73 days
- Class
- Class II
- Product code
- GXI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972846 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK972846 BMC RF CannulaBaylis Medical Co., Inc. · 1998 · Recalled
- This deviceK092337 Pain Management Optima, Model PMO21-100-05, PMO20-100-10CS…Baylis Medical Co., Inc. · 2009
- Descendant · cites it directly · 0 of its ownK101372 Duocool Pain Management Probe, Model Osp-17-180-20Baylis Medical Co., Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K101372Duocool Pain Management Probe, Model Osp-17-180-20Baylis Medical Co., Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972846 | BMC RF Cannula | Baylis Medical Co., Inc. | 1998 | 2 |
| 0 (this device) | K092337 | Pain Management Optima, Model PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS | Baylis Medical Co., Inc. | 2009 | — |
| +1 | K101372 | Duocool Pain Management Probe, Model Osp-17-180-20 | Baylis Medical Co., Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 GXI? 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 GXI device
- #1 K253907 Disposable Radiofrequency Cannulascore 12.7 · 6 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 |
|---|---|---|---|
| * | K972846 | BMC RF CannulaSummary page 1…Device Code: GX1 Identification of Predicate Device Predicate device is the BMC RF Cannula, which is cleared under 510(k) Premarket Notification Number K972846 Device Description The Pain Management Optima is a sterile, single-use cannula with an integrated probe used to d… | 1998 |
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 |
|---|---|---|---|
| K101372 | Duocool Pain Management Probe, Model Osp-17-180-20 | 2010 | 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?
How does its category compare?
All GXI devicesGXI Probe, Radiofrequency Lesion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GXI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXI
183in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXI
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXI
98in 2025
MAUDE reports naming product code GXI, 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 | 4 | 87 | 3 | 1 |
| 2008 | 2 | — | 1 | 4 |
| 2009 | 2 | — | 0 | 10 |
| 2010 | 2 | — | 1 | 8 |
| 2011 | 3 | 64 | 0 | 5 |
| 2012 | 1 | — | 1 | 14 |
| 2013 | 1 | — | 1 | 25 |
| 2014 | 1 | — | 0 | 20 |
| 2015 | 1 | — | 0 | 23 |
| 2016 | 3 | 240 | 0 | 16 |
| 2017 | 3 | 125 | 1 | 150 |
| 2018 | 1 | — | 0 | 147 |
| 2019 | 3 | 63 | 1 | 93 |
| 2020 | 3 | 255 | 0 | 31 |
| 2021 | 0 | — | 0 | 30 |
| 2022 | 2 | — | 0 | 46 |
| 2023 | 0 | — | 0 | 35 |
| 2024 | 0 | — | 0 | 45 |
| 2025 | 4 | 183 | 0 | 98 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
The Pain Management Optima is intended for use in radiofrequency (RF) heat lesion procedures for relief of pain
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092337 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092337: Pain Management Optima, Model PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092337
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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