510(k) · Cleared
Recalled · Class II · 2023Clearblue® Early Digital Pregnancy Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spd Swiss Precision Diagnostics GmbH · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Aug 13, 2021 as substantially equivalent to K123567 (Church & Dwight Co., Inc., 2013) after a 494-day review. Its family tree reaches back 4 generations to 1999. It has been recalled 2 times.
- Decided
- Aug 13, 2021
- Review
- 494 days
- Class
- Class II
- Product code
- LCX
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K992232 (1999). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK992232 First Response 1-Step PregnancyArmkel, LLC · 1999
- 3 generations backK030258 First Response Pregnancy TestArmkel, LLC · 2003
- 2 generations backK083716 First Response Early Result Pregnancy Test (Otc)Church & Dwight Co., Inc. · 2009 · Recalled
- 1 generation backK123567 First Response Gold Digital Pregnancy TestChurch & Dwight Co., Inc. · 2013
- This deviceK200913 Clearblue® Early Digital Pregnancy TestSpd Swiss Precision Diagnostics GmbH · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K992232 | First Response 1-Step Pregnancy | Armkel, LLC | 1999 | — |
| −3 | K030258 | First Response Pregnancy Test | Armkel, LLC | 2003 | — |
| −2 | K083716 | First Response Early Result Pregnancy Test (Otc) | Church & Dwight Co., Inc. | 2009 | 1 |
| −1 | K123567 | First Response Gold Digital Pregnancy Test | Church & Dwight Co., Inc. | 2013 | — |
| 0 (this device) | K200913 | Clearblue® Early Digital Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | 2021 | — |
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 |
|---|---|---|---|
| * | K123567 | First Response Gold Digital Pregnancy TestSummary page 4…egulation Description: Human chorionic gonadotropin (hCG) test system Regulation number: 21CFR 862.1155 E. Predicate Device: k123567, FIRST RESPONSE™ Gold Digital Pregnancy Test (k123567)… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 4, 2023 | Class II | Z-0261-2024 | Storage | Products were stored outside of labeled temperature requirements. |
| Jun 23, 2022 | Class II | Z-1526-2022 | Storage | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 1 other device also cites its predicate K123567.
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. 2021, 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 Clearblue® Early Digital Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. This digital test 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 test is intended for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200913 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200913: Clearblue® Early Digital Pregnancy Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200913
Report an extraction error
Are you the manufacturer?
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