510(k) · Cleared
ClearedHPR45i
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
F Care Systems USA, LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 20, 2023 as substantially equivalent to K081791 (Megadyne Medical Products, Inc., 2008) after a 371-day review. Its family tree reaches back 3 generations to 1978. 1 later device descends from it.
- Decided
- Mar 20, 2023
- Review
- 371 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K780977 (1978). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK780977 Single Use Blade ElectrodeAspen Laboratories, Inc. · 1978
- 2 generations backK960255 Ceramic Blade ElectrodeUtah Medical Products, Inc. · 1996
- 1 generation backK081791 E-Z Clean Electrosurgical ElectrodeMegadyne Medical Products, Inc. · 2008 · Recalled
- This deviceK220725 HPR45iF Care Systems USA, LLC · 2023
- Descendant · cites it directly · 0 of its ownK252704 F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE…F Care Systems USA, LLC · 2025
Most influential descendants
Showing 1 of 1 · See all- K252704F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)F Care Systems USA, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K780977 | Single Use Blade Electrode | Aspen Laboratories, Inc. | 1978 | — |
| −2 | K960255 | Ceramic Blade Electrode | Utah Medical Products, Inc. | 1996 | — |
| −1 | K081791 | E-Z Clean Electrosurgical Electrode | Megadyne Medical Products, Inc. | 2008 | 1 |
| 0 (this device) | K220725 | HPR45i | F Care Systems USA, LLC | 2023 | — |
| +1 | K252704 | F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB… | F Care Systems USA, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 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 |
|---|---|---|---|
| * | K081791 | E-Z Clean Electrosurgical ElectrodeSummary page 5…quivalent Device: Table 2 Predicate Device 510(k) Number Device Name Manufacturer K081791 E-Z Clean Electrosurgical Megadyne Medical Electrode… | 2008 |
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 |
|---|---|---|---|
| K252704 | F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) | 2025 | 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?
- The line of descent spans 45 years and passes through 4 companies; a new generation was cleared every 14.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K252704 (F Care Systems USA, LLC, 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K081791.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
HPR45i electrosurgical electrode is intended to conduct radio frequency (RF) current for coagulation from the RF electrosurgical generator to target soft issue in a broad range of surgical procedures. The device is a prescription use (Rx) device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220725 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220725: HPR45i.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220725
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