510(k) · Cleared
ClearediHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Andon Health Co, Ltd. · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Dec 20, 2024 as substantially equivalent to K213379 (Spd Swiss Precision Diagnostics GmbH, 2022) after a 218-day review. Its family tree reaches back 5 generations to 1999.
- Decided
- Dec 20, 2024
- Review
- 218 days
- Class
- Class II
- Product code
- LCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K992232 (1999). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK992232 First Response 1-Step PregnancyArmkel, LLC · 1999
- 4 generations backK030258 First Response Pregnancy TestArmkel, LLC · 2003
- 3 generations backK083716 First Response Early Result Pregnancy Test (Otc)Church & Dwight Co., Inc. · 2009 · Recalled
- 2 generations backK123436 First Response Early Result Pregnancy TestChurch & Dwight Co., Inc. · 2013 · Recalled
- 1 generation backK213379 Clearblue ® Early Pregnancy TestSpd Swiss Precision Diagnostics GmbH · 2022
- This deviceK241394 iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripAndon Health Co, Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K992232 | First Response 1-Step Pregnancy | Armkel, LLC | 1999 | — |
| −4 | K030258 | First Response Pregnancy Test | Armkel, LLC | 2003 | — |
| −3 | K083716 | First Response Early Result Pregnancy Test (Otc) | Church & Dwight Co., Inc. | 2009 | 1 |
| −2 | K123436 | First Response Early Result Pregnancy Test | Church & Dwight Co., Inc. | 2013 | 2 |
| −1 | K213379 | Clearblue ® Early Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | 2022 | — |
| 0 (this device) | K241394 | iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip | Andon Health Co, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K213379 | Clearblue ® Early Pregnancy TestSummary page 5…Device Manufacturer: SPD Swiss Precision Diagnostics GmbH Device Name: Clearblue® Early Pregnancy Test 510(k) Number: K213379 Classification II Product Code： LCX 1 ===… | 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 25 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 6 ancestors have a recall of any class.
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?
The iHealth® Early Pregnancy Test is an OTC in vitro diagnostic test used to assess early pregnancy by detecting the presence of the hCG (human chorionic gonadotropin) hormone in urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e., as early as five (5) days before the day of the expected period. The iHealth® Early Pregnancy Test Strip is an…
Read the full statement (151 words)
The iHealth® Early Pregnancy Test is an OTC in vitro diagnostic test used to assess early pregnancy by detecting the presence of the hCG (human chorionic gonadotropin) hormone in urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e., as early as five (5) days before the day of the expected period.
The iHealth® Early Pregnancy Test Strip is an OTC in vitro diagnostic test used to assess early pregnancy by detecting the presence of the hCG (human chorionic gonadotropin) hormone in urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e., as early as five (5) days before the day of the expected period.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241394 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241394: iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241394
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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