510(k) · Cleared

Cleared

First Response Pregnancy Test

K030258510(k) TraditionalCleared Feb 25, 200332-day reviewClass II21 CFR 862.1155

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Armkel, LLC · LCX Kit, Test, Pregnancy, Hcg, Over The Counter

Cleared on Feb 25, 2003 as substantially equivalent to K992232 (Armkel, LLC, 1999) and 1 other predicate after a 32-day review. Its family tree reaches back 1 generation to 1999. 19 later devices descend from it.

Decided: Feb 25, 2003
Review: 32 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. 19 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK992232 First Response 1-Step PregnancyArmkel, LLC · 1999
This deviceK030258 First Response Pregnancy TestArmkel, LLC · 2003
Descendant · cites it directly · 17 of its ownK083716 First Response Early Result Pregnancy Test (Otc)Church & Dwight Co., Inc. · 2009 · Recalled
Descendant · 2 generations on · 13 of its ownK123436 First Response Early Result Pregnancy TestChurch & Dwight Co., Inc. · 2013 · Recalled
Descendant · 3 generations on · 6 of its ownK150022 Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG…Guangzhou Wondfo Biotech Co., Ltd. · 2015
Descendant · 2 generations on · 2 of its ownK123567 First Response Gold Digital Pregnancy TestChurch & Dwight Co., Inc. · 2013
Descendant · 3 generations on · 1 of its ownK213379 Clearblue ® Early Pregnancy TestSpd Swiss Precision Diagnostics GmbH · 2022

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2009high 4 (2024) · low 0 (2010)2026

Most influential descendants

Showing 5 of 19 · See all

K083716First Response Early Result Pregnancy Test (Otc)Church & Dwight Co., Inc. · 2009 · cites it directly17descendants
K123436First Response Early Result Pregnancy TestChurch & Dwight Co., Inc. · 2013 · 2 generations on13descendants
K150022Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test…Guangzhou Wondfo Biotech Co., Ltd. · 2015 · 3 generations on6descendants
K123567First Response Gold Digital Pregnancy TestChurch & Dwight Co., Inc. · 2013 · 2 generations on2descendants
K213379Clearblue ® Early Pregnancy TestSpd Swiss Precision Diagnostics GmbH · 2022 · 3 generations on1descendant

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)	K030258	First Response Pregnancy Test	Armkel, LLC	2003	—
+1	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
+3	K150022	Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine…	Guangzhou Wondfo Biotech Co., Ltd.	2015	—
+2	K123567	First Response Gold Digital Pregnancy Test	Church & Dwight Co., Inc.	2013	—
+3	K213379	Clearblue ® Early Pregnancy Test	Spd Swiss Precision Diagnostics GmbH	2022	—

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
2009	1	0
2012	1	0
2013	2	0
2015	1	0
2017	1	0
2019	2	0
2020	1	0
2021	1	0
2022	2	0
2024	4	0
2025	3	0

FIG. 1 — Lineage of K030258, 1999–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K992232	First Response 1-Step Pregnancy Summary page 1 …E@ Pregnancy Test (FR) Clearblue Easy@ Early Result Pregnancy Test (CH) B 510(k) number(s): K992232 (FR), KO13372 (CB) C Comparison with predicate: The subject device and the predicate v…	Armkel, LLC	1999	—
*	K013372	Clearblue Easy Early Result Pregnancy Test	Unipath, Ltd.	2001	—

Also cleared against K992232: 2 other devices →

What descends from it? (19)

See all 19

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K083716	First Response Early Result Pregnancy Test (Otc)	Church & Dwight Co., Inc.	2009	17
K112449	Quikresponse One Step Midstream Early Pregrancy Test	Tianjin New Bay Bioresearch Co., Ltd.	2012	0

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.
Of its descendants, K083716 (Church & Dwight Co., Inc., 2009) has gone furthest, with 17 descendants of its own.
2 other devices also cite its predicate K992232.

How does its category compare?

All LCX devices

LCX 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

2007high 10 (2024) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LCX

102in 2025

2007high 264 (2022) · low 50 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LCX

1in 2025

2007high 8 (2023) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LCX

6in 2025

2007high 45 (2008) · low 1 (2017)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®1-Step Pregnancy Test is an in vitro diagnostic test device intended for the early detection of pregnancy by the lay user up to four (4) days prior to the expected menses

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030258 · printed Nov 3, 2026

Cite this page

510(k) Report. “K030258: First Response 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/K030258

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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