510(k) · Cleared
ClearedAaron 1200 High Frequency Electrosurgical Generator, Model A1200 Aaron 1200 High Frequency Electrosurgical Generator Mod
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aaron Medical Industries · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 14, 1998 as substantially equivalent to K980366 (Aaron Medical Industries, 1998) and 2 other predicates after a 133-day review. Its family tree reaches back 2 generations to 1983.
- Decided
- Sep 14, 1998
- Review
- 133 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K823924 (1983). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK823924 Model SSE4 Electrosurgical GeneratorValleylab, Inc. · 1983
- 1 generation backK980366 Aaron 1200 High Frequency Electrosurgicl Generator A1200, A1200/240Aaron Medical Industries · 1998
- This deviceK981570 Aaron 1200 High Frequency Electrosurgical Generator, Model A1200…Aaron Medical Industries · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K823924 | Model SSE4 Electrosurgical Generator | Valleylab, Inc. | 1983 | — |
| −1 | K980366 | Aaron 1200 High Frequency Electrosurgicl Generator A1200, A1200/240 | Aaron Medical Industries | 1998 | — |
| 0 (this device) | K981570 | Aaron 1200 High Frequency Electrosurgical Generator, Model A1200 Aaron 1200… | Aaron Medical Industries | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 |
|---|---|---|---|
| * | K980366 | Aaron 1200 High Frequency Electrosurgicl Generator A1200, A1200/240Summary page 1…ion with the Aaron 1200, The Aaron 1200 High Frequency Electrosurgical Generator is substantially equivalent to the Aaron 1200 High Frequency Electrosurgical Generator (K980366), the Aaron 800 High Frequency Desiccator (K955681) and ValleyLab SSE4 Electrosurgical Generator (K823924) in design, operation,… | 1998 |
| * | K955681 | Aaron 800 High Frequency Desiccator/HandpieceSummary page 1…ency Electrosurgical Generator is substantially equivalent to the Aaron 1200 High Frequency Electrosurgical Generator (K980366), the Aaron 800 High Frequency Desiccator (K955681) and ValleyLab SSE4 Electrosurgical Generator (K823924) in design, operation, intended use, materials, energy source, components,… | 1996 |
| * | K823924 | Model SSE4 Electrosurgical GeneratorSummary page 1…ent to the Aaron 1200 High Frequency Electrosurgical Generator (K980366), the Aaron 800 High Frequency Desiccator (K955681) and ValleyLab SSE4 Electrosurgical Generator (K823924) in design, operation, intended use, materials, energy source, components, method of preparation and performance claims. Testing… | 1983 |
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 15 years and passes through 2 companies; a new generation was cleared every 15.1 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K980366.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Aaron 1200 is intended to be used for large loop excision of the transformation zone, loop electrosurgical excision procedures and other similar low powered procedures in the area of obstetrics and gynecology. LLETZ is indicated for those patients who have had an abnormal pap smear report with cytologic evidence of CIN, colposcopic examination of the cervix with unsatisfactory findings and who, in the physician’s opinion are suitable candidates for…
Read the full statement (134 words)
The Aaron 1200 is intended to be used for large loop excision of the transformation zone,
loop electrosurgical excision procedures and other similar low powered procedures in the
area of obstetrics and gynecology. LLETZ is indicated for those patients who have had an
abnormal pap smear report with cytologic evidence of CIN, colposcopic examination of
the cervix with unsatisfactory findings and who, in the physician’s opinion are suitable
candidates for the procedure. Indications for the LLETZ procedure include::
a cytological and colposcopic suspicion of CIN
a transformation zone which is fully visible and fully confined to the cervix
a suspicion (cytological or colposcopic) of glandular abnormalities
a recurrent and troublesome cervical infection with persistent atypicality
a disparity between the cytological and colposcopic diagnosis
a suspicion supported by evidence (cytological or colposcopic) of microinvasive
disease
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/K981570 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981570: Aaron 1200 High Frequency Electrosurgical Generator, Model A1200 Aaron 1200 High Frequency Electrosurgical Generator Mod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981570
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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