510(k) · Cleared
ClearedPK AIM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Acmi, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Dec 17, 2015 as substantially equivalent to K813071 (Valleylab, Inc., 1981) and 2 other predicates after a 132-day review. Its family tree reaches back 7 generations to 1992. 3 later devices descend from it.
- Decided
- Dec 17, 2015
- Review
- 132 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K923332 (1992). 23 ancestors in all, the oldest K813071 (1981). 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK923332 Electrosurgical ElectrodesPremier Dental Products Co. · 1992
- 6 generations backK970987 Electrosurgical ElectrodeFusion Medical Technologies, Inc. · 1997
- 5 generations backK992931 Non-Stick Bipolar ForcepsSilverglide Surgical Technologies · 1999
- 4 generations backK051429 Claris Non-Stick Bipolar ForcepsGuenter Bissinger Medizintechnik GmbH · 2005
- 3 generations backK070997 Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro…Pro-Med Instruments GmbH · 2007
- 2 generations backK083162 Stingray Electrosurgical ForcepsStingray Surgical Products, Inc. · 2009 · Recalled
- 1 generation backK093108 Stryker Bipolar ForcepsStryker Leibinger GmbH & Co KG · 2010
- This deviceK152219 PK AIMGyrus Acmi, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK161825 PK AIMGyrus Acmi, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK163373 PK AIMGyrus Acmi, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK170908 PK AIMGyrus Acmi, Inc. · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K923332 | Electrosurgical Electrodes | Premier Dental Products Co. | 1992 | — |
| −6 | K970987 | Electrosurgical Electrode | Fusion Medical Technologies, Inc. | 1997 | — |
| −5 | K992931 | Non-Stick Bipolar Forceps | Silverglide Surgical Technologies | 1999 | — |
| −4 | K051429 | Claris Non-Stick Bipolar Forceps | Guenter Bissinger Medizintechnik GmbH | 2005 | — |
| −3 | K070997 | Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro Bipolar… | Pro-Med Instruments GmbH | 2007 | — |
| −2 | K083162 | Stingray Electrosurgical Forceps | Stingray Surgical Products, Inc. | 2009 | 1 |
| −1 | K093108 | Stryker Bipolar Forceps | Stryker Leibinger GmbH & Co KG | 2010 | — |
| 0 (this device) | K152219 | PK AIM | Gyrus Acmi, Inc. | 2015 | — |
| +1 | K161825 | PK AIM | Gyrus Acmi, Inc. | 2016 | — |
| +2 | K163373 | PK AIM | Gyrus Acmi, Inc. | 2016 | — |
| +3 | K170908 | PK AIM | Gyrus Acmi, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 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? (3)
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 |
|---|---|---|---|
| * | K813071 | E2508 Disposable Handswitching PencilSummary page 5…l cutting and coagulation device 10 K152219 Page 2 of 5 Olympus - PK AIM Traditional 510(k) Notification Gyrus ACMI, Inc. July 2015 Predicate Devices K813071 ValleyLab/Covidien Electrosurgical Pencil (monopolar pencil) K093108 Stryker Bipolar Forceps (bipolar forceps) K063195 ValleyLab… | 1981 |
| * | K093108 | Stryker Bipolar ForcepsSummary page 5…f 5 Olympus - PK AIM Traditional 510(k) Notification Gyrus ACMI, Inc. July 2015 Predicate Devices K813071 ValleyLab/Covidien Electrosurgical Pencil (monopolar pencil) K093108 Stryker Bipolar Forceps (bipolar forceps) K063195 ValleyLab LigaSure Advance (dual plugs) Comparison to Predicate Devices: The… | 2010 |
| * | K063195 | Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models LF5034…Summary page 5…ion Gyrus ACMI, Inc. July 2015 Predicate Devices K813071 ValleyLab/Covidien Electrosurgical Pencil (monopolar pencil) K093108 Stryker Bipolar Forceps (bipolar forceps) K063195 ValleyLab LigaSure Advance (dual plugs) Comparison to Predicate Devices: The Olympus - PK AIM has been compared to the above me… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161825 | PK AIM | 2016 | 2 |
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 8 companies; a new generation was cleared every 2.5 years on median.
- 6 of the 23 ancestors have a recall of any class.
- Of its descendants, K161825 (Gyrus Acmi, Inc., 2016) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K813071.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 PK AIM device is intended for monopolar cutting as well as grasping, manipulating and bipolar coagulation of selected soft tissues during electrosurgery. This device is not intended to be used for tubal ligation or female sterilization.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152219: PK AIM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152219
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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