510(k) · Cleared
ClearedDuocool Pain Management Probe, Model Osp-17-180-20
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 Aug 10, 2010 as substantially equivalent to K092337 (Baylis Medical Co., Inc., 2009) after an 85-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Aug 10, 2010
- Review
- 85 days
- Class
- Class II
- Product code
- GXI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K972846 (1998). No later device cites it as a predicate yet.
- Root · 2 generations backK972846 BMC RF CannulaBaylis Medical Co., Inc. · 1998 · Recalled
- 1 generation backK092337 Pain Management Optima, Model PMO21-100-05, PMO20-100-10CS…Baylis Medical Co., Inc. · 2009
- This deviceK101372 Duocool Pain Management Probe, Model Osp-17-180-20Baylis Medical Co., Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972846 | BMC RF Cannula | Baylis Medical Co., Inc. | 1998 | 2 |
| −1 | K092337 | Pain Management Optima, Model PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS | Baylis Medical Co., Inc. | 2009 | — |
| 0 (this device) | K101372 | Duocool Pain Management Probe, Model Osp-17-180-20 | Baylis Medical Co., Inc. | 2010 | — |
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 |
|---|---|---|---|
| * | K092337 | Pain Management Optima, Model PMO21-100-05, PMO20-100-10CS, PMO20-145-10CSSummary page 1…II F. Device Code: GXI Identification of Predicate Device Predicate device is the Pain Management Optima, which is cleared under 5 10(k) Premarket Notification Number K092337 Device Description The DuoCool Pain Management Probe is a sterile, single-use probe used to deliver Radio- Frequency (RF) energ… | 2009 |
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 12 years and passes through 1 company; a new generation was cleared every 11.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All GXI devicesGXI Probe, Radiofrequency Lesion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 DuoCool Pain Management Probe (probe model number: OSP-17-150-20; kit model number: OSK-i17-180-20) 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/K101372 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101372: Duocool Pain Management Probe, Model Osp-17-180-20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101372
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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