510(k) · Cleared
ClearedB-D Digital Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Becton Dickinson Vacutainer Systems Preanalytic · LHD Device, Fertility Diagnostic, Proceptive
Cleared on Jun 15, 1995 after a 223-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- Jun 15, 1995
- Review
- 223 days
- Class
- Class U
- Product code
- LHD
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK945427 B-D Digital ThermometerBd Becton Dickinson Vacutainer Systems Preanalytic · 1995
- Descendant · cites it directly · 11 of its ownK062784 Sejoy Digital Thermometer, MT Series (MT-201, MT-301, MT-402, MT-403…Sejoy Electronics & Instruments Co., Ltd. · 2007
- Descendant · 2 generations on · 8 of its ownK110776 Digital Thermometer MT SeriesSejoy Electronics & Instruments Co., Ltd. · 2011
- Descendant · 3 generations on · 7 of its ownK153149 Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132…Sejoy Electronics & Instruments Co., Ltd. · 2016
- Descendant · 4 generations on · 6 of its ownK163518 Digital ThermometerJoytech Healthcare Co., Ltd. · 2017
- Descendant · 5 generations on · 4 of its ownK183393 Digital ThermometerJoytech Healthcare Co., Ltd. · 2019
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K062784Sejoy Digital Thermometer, MT Series (MT-201, MT-301, MT-402, MT-403 and MT-405)Sejoy Electronics & Instruments Co., Ltd. · 2007 · cites it directly11descendants
- K110776Digital Thermometer MT SeriesSejoy Electronics & Instruments Co., Ltd. · 2011 · 2 generations on8descendants
- K153149Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326…Sejoy Electronics & Instruments Co., Ltd. · 2016 · 3 generations on7descendants
- K163518Digital ThermometerJoytech Healthcare Co., Ltd. · 2017 · 4 generations on6descendants
- K183393Digital ThermometerJoytech Healthcare Co., Ltd. · 2019 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K945427 | B-D Digital Thermometer | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995 | — |
| +1 | K062784 | Sejoy Digital Thermometer, MT Series (MT-201, MT-301, MT-402, MT-403 and MT-405) | Sejoy Electronics & Instruments Co., Ltd. | 2007 | — |
| +2 | K110776 | Digital Thermometer MT Series | Sejoy Electronics & Instruments Co., Ltd. | 2011 | — |
| +3 | K153149 | Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333… | Sejoy Electronics & Instruments Co., Ltd. | 2016 | — |
| +4 | K163518 | Digital Thermometer | Joytech Healthcare Co., Ltd. | 2017 | — |
| +5 | K183393 | Digital Thermometer | Joytech Healthcare Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062784 | Sejoy Digital Thermometer, MT Series (MT-201, MT-301, MT-402, MT-403 and MT-405) | 2007 | 11 |
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?
- Of its descendants, K062784 (Sejoy Electronics & Instruments Co., Ltd., 2007) has gone furthest, with 11 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.
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 | — |
https://510kreport.com/device/K945427 · printed Nov 6, 2026
Cite this page
510(k) Report. “K945427: B-D Digital Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945427
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026