510(k) · Cleared
ClearedMicrolife Digital Basal Thermometer, Model MT 1921
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microlife Corp. · LHD Device, Fertility Diagnostic, Proceptive
Cleared on Sep 12, 2003 after a 169-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- Sep 12, 2003
- Review
- 169 days
- Class
- Class U
- Product code
- LHD
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
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 LHD? 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 LHD device
- #1 K200163 Ava Fertility Trackerscore 0.7 · 1 generation · no Class I recall
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K094527 | B-D Digital Basal Thermometer, Model 524560 Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree |
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 LHD devicesLHD Device, Fertility Diagnostic, Proceptive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LHD
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LHD
Too few LHD 510(k)s in any year since 2007 to give a median.
Recalls per year · LHD
No recall names LHD since 2007.
Adverse event reports per year · LHD
1in 2023
MAUDE reports naming product code LHD, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 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 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Microlife Digital Basal Thermometer is a device intended for measuring, and
aiding in the monitoring and tracking of basal body temperature (BBT) as an aid
in ovulation prediction to aid in conception (not to be used for contraception).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030961: Microlife Digital Basal Thermometer, Model MT 1921.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030961
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026