510(k) · Cleared
Recalled · Class II · 2023First Response Early Result Pregnancy Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Church & Dwight Co., Inc. · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Aug 26, 2013 as substantially equivalent to K083716 (Church & Dwight Co., Inc., 2009) after a 292-day review. Its family tree reaches back 3 generations to 1999. 13 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 26, 2013
- Review
- 292 days
- Class
- Class II
- Product code
- LCX
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K992232 (1999). 4 ancestors in all. 13 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK992232 First Response 1-Step PregnancyArmkel, LLC · 1999
- 2 generations backK030258 First Response Pregnancy TestArmkel, LLC · 2003
- 1 generation backK083716 First Response Early Result Pregnancy Test (Otc)Church & Dwight Co., Inc. · 2009 · Recalled
- This deviceK123436 First Response Early Result Pregnancy TestChurch & Dwight Co., Inc. · 2013
- Descendant · cites it directly · 6 of its ownK150022 Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG…Guangzhou Wondfo Biotech Co., Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK213379 Clearblue ® Early Pregnancy TestSpd Swiss Precision Diagnostics GmbH · 2022
- Descendant · 2 generations on · 0 of its ownK251040 MissLan® Early Detection Digital Pregnancy Test; MissLan® Early…Guangzhou Decheng Biotechnology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK251053 Shinetell PlusTM Digital Early Pregnancy TestHangzhou AllTest Biotech Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK243573 FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy…Assure Tech., LLC · 2025
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K150022Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test…Guangzhou Wondfo Biotech Co., Ltd. · 2015 · cites it directly6descendants
- K213379Clearblue ® Early Pregnancy TestSpd Swiss Precision Diagnostics GmbH · 2022 · cites it directly1descendant
- K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy…Guangzhou Decheng Biotechnology Co., Ltd. · 2025 · 2 generations on0descendants
- K251053Shinetell PlusTM Digital Early Pregnancy TestHangzhou AllTest Biotech Co., Ltd. · 2025 · 2 generations on0descendants
- K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette…Assure Tech., LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K992232 | First Response 1-Step Pregnancy | Armkel, LLC | 1999 | — |
| −2 | K030258 | First Response Pregnancy Test | Armkel, LLC | 2003 | — |
| −1 | K083716 | First Response Early Result Pregnancy Test (Otc) | Church & Dwight Co., Inc. | 2009 | 1 |
| 0 (this device) | K123436 | First Response Early Result Pregnancy Test | Church & Dwight Co., Inc. | 2013 | — |
| +1 | K150022 | Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine… | Guangzhou Wondfo Biotech Co., Ltd. | 2015 | — |
| +1 | K213379 | Clearblue ® Early Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | 2022 | — |
| +2 | K251040 | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital… | Guangzhou Decheng Biotechnology Co., Ltd. | 2025 | — |
| +2 | K251053 | Shinetell PlusTM Digital Early Pregnancy Test | Hangzhou AllTest Biotech Co., Ltd. | 2025 | — |
| +2 | K243573 | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test… | Assure Tech., LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K083716 | First Response Early Result Pregnancy Test (Otc) | 2009 |
What descends from it? (13)
See all 136 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150022 | Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test… | 2015 | 6 |
| K213379 | Clearblue ® Early Pregnancy Test | 2022 | 1 |
| K212418 | hCG One Step Pregnancy Test | 2022 | 0 |
| K193318 | Distinct® Early Detection Pregnancy Test | 2020 | 0 |
| K181551 | DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test… | 2019 | 0 |
| K172257 | TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result… | 2017 | 0 |
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-0266-2024 | Storage | Products were stored outside of labeled temperature requirements. |
| Jun 23, 2022 | Class II | Z-1537-2022 | 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 14 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K150022 (Guangzhou Wondfo Biotech Co., Ltd., 2015) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K083716.
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. 2013, 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 FIRST RESPONSE Early Result Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorioriic gonadotropin (hCG) in urine. The device is intended for use as an aid in early detection of pregnancy, in same cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. Important note regarding negative results: Some pregnant women will not…
Read the full statement (177 words)
The FIRST RESPONSE Early Result Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorioriic gonadotropin (hCG) in urine. The device is intended for use as an aid in early detection of pregnancy, in same cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.
Important note regarding negative results:
Some pregnant women will not be able to detect hCG in their urine 5 days before the expected period. If you test negative before your missed period, but think you may still be pregnant, you should test again a few days after your missed period.
Important note regarding positive results:
Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. If you test positive, but think you may not be pregnant, you should check with your doctor.
All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123436 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123436: First Response Early Result 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/K123436
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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