510(k) · Cleared
ClearedDuofertility
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cambridge Temperature Concepts, Ltd. · LHD Device, Fertility Diagnostic, Proceptive
Cleared on Dec 20, 2011 as substantially equivalent to K021978 (Nishitomo Co., Inc., 2003) and 2 other predicates after a 476-day review. Its family tree reaches back 3 generations to 1991. 1 later device descends from it.
- Decided
- Dec 20, 2011
- Review
- 476 days
- Class
- Class U
- Product code
- LHD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K914085 (1991). 6 ancestors in all, the oldest K901512 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK914085 HMS-5000Vitalog Monitoring,Inc. · 1991
- 2 generations backK991045 Mini-Logger Series 2000Mini-Mitter Co., Inc. · 1999
- 1 generation backK033534 VitalsenseMini-Mitter Co., Inc. · 2004
- This deviceK102499 DuofertilityCambridge Temperature Concepts, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK122337 OvusenseFertility Focus, Ltd. · 2013
Most influential descendants
Showing 1 of 1 · See all- K122337OvusenseFertility Focus, Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K914085 | HMS-5000 | Vitalog Monitoring,Inc. | 1991 | — |
| −2 | K991045 | Mini-Logger Series 2000 | Mini-Mitter Co., Inc. | 1999 | — |
| −1 | K033534 | Vitalsense | Mini-Mitter Co., Inc. | 2004 | — |
| 0 (this device) | K102499 | Duofertility | Cambridge Temperature Concepts, Ltd. | 2011 | — |
| +1 | K122337 | Ovusense | Fertility Focus, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 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? (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 |
|---|---|---|---|
| * | K021978 | Petit SophiaSummary page 2…Device, fertility diagnostic, proceptive Product Code: LHD DuoFertility Premarket Notification Submission Predicate devices K021978 Nishitomo Co., Ltd. Petit Sophia K050094 Lady-Comp USA. Lady-Comp K033534 Mini-Mitter Co., Inc. VitalSense Description of devi… | 2003 |
| * | K050094 | Lady Comp UsaSummary page 2…ceptive Product Code: LHD DuoFertility Premarket Notification Submission Predicate devices K021978 Nishitomo Co., Ltd. Petit Sophia K050094 Lady-Comp USA. Lady-Comp K033534 Mini-Mitter Co., Inc. VitalSense Description of device The DuoFertility system is a computeri… | 2006 |
| * | K033534 | VitalsenseSummary page 2…LHD DuoFertility Premarket Notification Submission Predicate devices K021978 Nishitomo Co., Ltd. Petit Sophia K050094 Lady-Comp USA. Lady-Comp K033534 Mini-Mitter Co., Inc. VitalSense Description of device The DuoFertility system is a computerized basal body temperature thermom… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122337 | Ovusense | 2013 | 0 |
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 20 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K122337 (Fertility Focus, Ltd., 2013) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LHD devicesLHD Device, Fertility Diagnostic, Proceptive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 DuoFertility Monitor is intended for measuring, and recording 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/K102499 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102499: Duofertility.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102499
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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