510(k) · Cleared
Recalled · Class II · 2016Germ Terminator GT 100 Toothbrush Sanitizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Germ Terminator Corporation · MCF Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile
Cleared on May 10, 2002 as substantially equivalent to K003517 (Otres, LLC, 2001) after a 21-day review. Its family tree reaches back 1 generation to 2001. It has been recalled once.
- Decided
- May 10, 2002
- Review
- 21 days
- Class
- Class I
- Product code
- MCF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003517 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK003517 Otres Toothbrush Sanitizer Model TB100WOtres, LLC · 2001
- This deviceK021258 Germ Terminator GT 100 Toothbrush SanitizerGerm Terminator Corporation · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003517 | Otres Toothbrush Sanitizer Model TB100W | Otres, LLC | 2001 | — |
| 0 (this device) | K021258 | Germ Terminator GT 100 Toothbrush Sanitizer | Germ Terminator Corporation | 2002 | — |
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 MCF? 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 |
|---|---|---|---|
| * | K003517 | Otres Toothbrush Sanitizer Model TB100WSummary page 1…0, 2002 Germ Terminator Toothbrush Sanitizer Toothbrush Sanitizer Toothbrush, Menual The subject device is substantially equivalent to the Otres Toothbrush Sanitizer (K003517). The Germ Terminator uses steam heat to sanitize (wo manual toothbrushes or two toothbrush heads. Water is poured into a reserv… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 5, 2016 | Class II | Z-2047-2016 | Unknown/Undetermined by firm | CEG Enterprises, LLC is recalling Germ Terminator Toothbrush Sanitizer GT100 due to the following issues: UL label believed to be not genuine; discoloration of power cords (could indicate some degradation); reports of excessive heat. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All MCF devicesMCF Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MCF
FDA has decided no MCF device since 2007.
Median 510(k) review, days · MCF
Too few MCF 510(k)s in any year since 2007 to give a median.
Recalls per year · MCF
No recall names MCF since 2007.
Adverse event reports per year · MCF
No MAUDE report names MCF 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 Germ Terminator Toothbrush Sanitizer is designed to sanitize up to two manual toothbrushes or two toothbrush heads between uses.
The Germ Terminator Toothbrush Sanitizer is intended for home use and will be available “over the counter.”
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/K021258 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021258: Germ Terminator GT 100 Toothbrush Sanitizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021258
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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