510(k) · Cleared
ClearedPetit Sophia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nishitomo Co., Inc. · LHD Device, Fertility Diagnostic, Proceptive
Cleared on Apr 8, 2003 as substantially equivalent to K901512 (Nishitomo Co., Inc., 1990) after a 295-day review. Its family tree reaches back 1 generation to 1990. 2 later devices descend from it.
- Decided
- Apr 8, 2003
- Review
- 295 days
- Class
- Class U
- Product code
- LHD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K901512 (1990). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK901512 L SophiaNishitomo Co., Inc. · 1990
- This deviceK021978 Petit SophiaNishitomo Co., Inc. · 2003
- Descendant · cites it directly · 1 of its ownK102499 DuofertilityCambridge Temperature Concepts, Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK122337 OvusenseFertility Focus, Ltd. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K901512 | L Sophia | Nishitomo Co., Inc. | 1990 | — |
| 0 (this device) | K021978 | Petit Sophia | Nishitomo Co., Inc. | 2003 | — |
| +1 | K102499 | Duofertility | Cambridge Temperature Concepts, Ltd. | 2011 | — |
| +2 | K122337 | Ovusense | Fertility Focus, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K901512 | L SophiaSummary page 1…Class: II Predicate Device: Nishitomo, L Sophia, BT-01 K 901512 Device Description: This device is the clinical thermometer with memory… | 1990 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102499 | Duofertility | 2011 | 1 |
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.
- Of its descendants, K102499 (Cambridge Temperature Concepts, Ltd., 2011) has gone furthest, with 1 descendant 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.
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?
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/K021978 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021978: Petit Sophia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021978
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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