510(k) · Cleared
ClearedShinetell Digital Pregnancy Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou AllTest Biotech Co., Ltd. · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Aug 13, 2024 as substantially equivalent to K222305 (Guangzhou Decheng Biotechnology Co., Ltd., 2022) after a 39-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Aug 13, 2024
- Review
- 39 days
- Class
- Class II
- Product code
- LCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K941090 (1994). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK941090 Unistep HCG Pregnancy Test StripBiotech Atlantic, Inc. · 1994
- 5 generations backK960174 Unimark Midstream Pregnancy Test StickBiotech Atlantic, Inc. · 1996
- 4 generations backK032992 Unimark Home Pregnancy Test DeviceBiotech Atlantic, Inc. · 2003
- 3 generations backK043443 One Step HCG Urine Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. · 2005
- 2 generations backK173229 Preview Digital Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. · 2018
- 1 generation backK222305 MissLan™ Digital Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., Ltd. · 2022
- This deviceK241978 Shinetell Digital Pregnancy TestHangzhou AllTest Biotech Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K941090 | Unistep HCG Pregnancy Test Strip | Biotech Atlantic, Inc. | 1994 | — |
| −5 | K960174 | Unimark Midstream Pregnancy Test Stick | Biotech Atlantic, Inc. | 1996 | — |
| −4 | K032992 | Unimark Home Pregnancy Test Device | Biotech Atlantic, Inc. | 2003 | — |
| −3 | K043443 | One Step HCG Urine Pregnancy Test | Guangzhou Wondfo Biotech Co., Ltd. | 2005 | — |
| −2 | K173229 | Preview Digital Pregnancy Test | Guangzhou Wondfo Biotech Co., Ltd. | 2018 | — |
| −1 | K222305 | MissLan™ Digital Pregnancy Rapid Test | Guangzhou Decheng Biotechnology Co., Ltd. | 2022 | — |
| 0 (this device) | K241978 | Shinetell Digital Pregnancy Test | Hangzhou AllTest Biotech Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 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 LCX? 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 LCX device
- #1 K251040 MissLan® Early Detection Digital Pregnancy…score 11.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K222305 | MissLan™ Digital Pregnancy Rapid TestSummary page 4…Class II Product Code: LCX CFR: 862.1155 5. Predicate Devices: MissLanä Digital Pregnancy Rapid Test (K222305) 6. Intended Use Shinetellä Digital Pregnancy Test is a pregnancy test. It is used for the qualitative detection of hCG in human… | 2022 |
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?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- None of the 10 ancestors has a recall.
How does its category compare?
All LCX devicesLCX Kit, Test, Pregnancy, Hcg, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · LCX
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LCX
102in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LCX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LCX
6in 2025
MAUDE reports naming product code LCX, 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 | 4 | 223 | 0 | 26 |
| 2008 | 0 | — | 0 | 45 |
| 2009 | 2 | — | 1 | 8 |
| 2010 | 0 | — | 2 | 21 |
| 2011 | 5 | 234 | 0 | 19 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 8 | 152 | 0 | 3 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 4 | 162 | 0 | 2 |
| 2019 | 7 | 50 | 0 | 3 |
| 2020 | 2 | — | 0 | 3 |
| 2021 | 2 | — | 0 | 4 |
| 2022 | 6 | 264 | 0 | 12 |
| 2023 | 2 | — | 8 | 6 |
| 2024 | 10 | 132 | 0 | 3 |
| 2025 | 5 | 102 | 1 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ShinetellTM Digital Pregnancy Test is a pregnancy test. It is used for the qualitative detection of hCG in human urine as an aid in early detection of pregnancy. For in vitro diagnostic use, for over the counter use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241978 · printed Nov 3, 2026
Cite this page
510(k) Report. “K241978: Shinetell Digital Pregnancy Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K241978
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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