510(k) · Cleared

Cleared

Amniscreen Home Detection Liner Kit

K071100510(k) TraditionalCleared Oct 15, 2007179-day reviewClass I21 CFR 862.1550

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

Common Sense, Ltd. · CEN Dye-Indicator, Ph (Urinary, Non-Quantitative)

Cleared on Oct 15, 2007 as substantially equivalent to K914419 (Pro-Lab, Inc., 1993) after a 179-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.

Decided: Oct 15, 2007
Review: 179 days
Class: Class I
Product code: CEN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K914419 (1993). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK914419 Amniotest (TM)Pro-Lab, Inc. · 1993
This deviceK071100 Amniscreen Home Detection Liner KitCommon Sense, Ltd. · 2007
Descendant · cites it directly · 0 of its ownK110605 Rom PlusClinical Innovations, LLC · 2011 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K110605Rom PlusClinical Innovations, LLC · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K914419	Amniotest (TM)	Pro-Lab, Inc.	1993	—
0 (this device)	K071100	Amniscreen Home Detection Liner Kit	Common Sense, Ltd.	2007	—
+1	K110605	Rom Plus	Clinical Innovations, LLC	2011	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0

FIG. 1 — Lineage of K071100, 1993–2011Source: 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 CEN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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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	Applicant	Decided	Recalls
*	K914419	Amniotest (TM) Summary page 1 …Classification name: Urinary pH (nonquantitative) test system 5.1.3. Identification of the legally marketed predicate device: AMNIOTEST(TM), 510(k) no: K914419 5.1.4. A description of the device: The AmniScreenTM Home Detection Liner Kit contains a Testing Panty-Liner (TPL) and a Dry…	Pro-Lab, Inc.	1993	—

Also cleared against K914419: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K110605	Rom Plus	Clinical Innovations, LLC	2011	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?

Its one ancestor has no recall.
Of its descendants, K110605 (Clinical Innovations, LLC, 2011) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K914419.

How does its category compare?

All CEN devices

CEN Dye-Indicator, Ph (Urinary, Non-Quantitative): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · CEN

1in 2009

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CEN

Too few CEN 510(k)s in any year since 2007 to give a median.

Recalls per year · CEN

2in 2025

2007high 2 (2025) · low 0 (2007)2026

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

Adverse event reports per year · CEN

1in 2018

2007high 3 (2012) · low 0 (2007)2025

MAUDE reports naming product code CEN, 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	1	—	0	0
2008	0	—	0	0
2009	1	—	0	0
2010	0	—	0	0
2011	0	—	0	0
2012	0	—	0	3
2013	0	—	0	0
2014	0	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	0	1
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	1	0
2024	0	—	0	0
2025	0	—	2	0
2026	0	—	1	—

What is it indicated for?

The AmniScreen Home Detection Liner Kit is intended to detect possible leakage of

amniotic fluid when vaginal wetness is experienced during pregnancy by indicating pH

level. pH levels greater than or equal to 5.2 produce a blue-green color. Patients are

instructed to report or show test results to their healthcare provider for interpretation and

medical care.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071100 · printed Nov 6, 2026

Cite this page

510(k) Report. “K071100: Amniscreen Home Detection Liner Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071100

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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