510(k) · Cleared
ClearedSeager Electroejaculator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
National Rehab Hospital · LNL Stimulator, Electrical For Sperm Collection
Cleared on Sep 18, 1997 after a 455-day review. The FDA summary names its predicate without a number.
- Decided
- Sep 18, 1997
- Review
- 455 days
- Class
- Class U
- Product code
- LNL
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 LNL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | A. Stiebel’s electroejaculation equipment Named without a submission number |
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.
How does its category compare?
All LNL devicesLNL Stimulator, Electrical For Sperm Collection: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LNL
FDA has decided no LNL device since 2007.
Median 510(k) review, days · LNL
Too few LNL 510(k)s in any year since 2007 to give a median.
Recalls per year · LNL
No recall names LNL since 2007.
Adverse event reports per year · LNL
No MAUDE report names LNL since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Seager Electroejaculator (EE) is intended to induce seminal emission in patients for whom prior or present illness precludes their ability to spontaneously ejaculate. The EE device is indicated for use in neurologically impaired males over the age of 18 years of age and who are anejaculatory due to the following conditions:
Spinal Cord Injury (paralysis)
Retroperitoneal Lymph Node Dissection (RPLND)
[surgical therapy post testicular cancer]
Idiopathic (neuropsychosis/psychogenic)
Diabetes
Spina Bifida
Pelvic Surgery Complications
Multiple Sclerosis (MS)
Neurological Impairments
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/K962379 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962379: Seager Electroejaculator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962379
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)
- Page last updated Nov 3, 2026