510(k) · Cleared
ClearedMiele Dental Thermal Disinfector, Model G7881
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Miele, Inc. · LDS Device, Pasteurization, Hot Water
Cleared on Nov 12, 2003 as substantially equivalent to K950518 (Miele Professional, 1996) after a 155-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Nov 12, 2003
- Review
- 155 days
- Class
- Class II
- Product code
- LDS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950518 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK950518 Miele G 7781 Dental Thermal DisinfectorMiele Professional · 1996
- This deviceK031799 Miele Dental Thermal Disinfector, Model G7881Miele, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950518 | Miele G 7781 Dental Thermal Disinfector | Miele Professional | 1996 | — |
| 0 (this device) | K031799 | Miele Dental Thermal Disinfector, Model G7881 | Miele, Inc. | 2003 | — |
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 LDS? 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 |
|---|---|---|---|
| * | K950518 | Miele G 7781 Dental Thermal DisinfectorSummary page 1…Marketed Substantial equivalence of the Miele G7881 Dental Thermal Disinfector exists to Device the Miele (3778 1 Dental Thermal Disinfector (K950518). The cycle parameters for high-level disinfection have not been changed from the (37781 Dental… | 1996 |
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?
- Its one ancestor has no recall.
How does its category compare?
All LDS devicesLDS Device, Pasteurization, Hot Water: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LDS
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · LDS
Too few LDS 510(k)s in any year since 2007 to give a median.
Recalls per year · LDS
4in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LDS
1in 2016
MAUDE reports naming product code LDS, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 4 | 1 |
| 2011 | 0 | — | 0 | 14 |
| 2012 | 0 | — | 0 | 63 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 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 Miele G 7881 Dental Thermal Disinfector is intended to clean and high-level disinfect heat stable reusable dental instruments and accessories using a thermal process. The cycle parameters for high-level disinfection are 93°C for 10 minutes. The Miele G7881 Dental Thermal Disinfector also has the following cleaning and high-level disinfection cycles:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031799 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031799: Miele Dental Thermal Disinfector, Model G7881.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031799
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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