510(k) · Cleared
ClearedFirst Response One-Step Digital Pregnancy Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Armkel, LLC · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Oct 19, 2004 as substantially equivalent to K992232 (Armkel, LLC, 1999) and 1 other predicate after a 200-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Oct 19, 2004
- Review
- 200 days
- Class
- Class II
- Product code
- LCX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K992232 (1999). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK992232 First Response 1-Step PregnancyArmkel, LLC · 1999
- This deviceK040866 First Response One-Step Digital Pregnancy TestArmkel, LLC · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992232 | First Response 1-Step Pregnancy | Armkel, LLC | 1999 | — |
| 0 (this device) | K040866 | First Response One-Step Digital Pregnancy Test | Armkel, LLC | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (2)
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 |
|---|---|---|---|
| * | K992232 | First Response 1-Step PregnancySummary page 1…Kit, Test, Pregnancy, hCO, Over-the-Counter Predicate Device: FIRST RESPONSE® One-Step Pregnancy Test -5 10(k) #K992232 and CLEAR BLUE® Easy Digital Pregnancy Test (Unipath Ltd., UK… | 1999 |
| * | K030659 | Clearblue Easy Digital Pregnancy TestSummary page 1…and CLEAR BLUE® Easy Digital Pregnancy Test (Unipath Ltd., UK) - 5 10(k) #1(030659 Description of Device: The FIRST RESPONSE® One-Step Digital Pregnancy Test is a human chorionic gonadotropin (hCG) test system.… | 2003 |
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?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K992232.
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.
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 FIRST RESPONSE® One-Step Digital Pregnancy Test is an in vitro diagnostic test device that incorporates a digital read out of the test result for the early detection of pregnancy (hCG in urine) by the lay user prior to the expected menses
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040866 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040866: First Response One-Step 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/K040866
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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