510(k) · Cleared
Recalled · Class I · 2020Amnisure Fetal Membranes Rupture Test, Model FMRT-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amnisure International, LLC · NQM Immunoassay For Detection Of Amniotic Fluid Protein (S).
Cleared on Jan 9, 2009 after a 203-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 2 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 2 times, including a Class I recall.
- Decided
- Jan 9, 2009
- Review
- 203 days
- Class
- Class I
- Product code
- NQM
- Recalls
- 2 (1 Class I)
- Predicates
- 0
1 later device descends from it, 1 citing it directly. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- This deviceK081767 Amnisure Fetal Membranes Rupture Test, Model FMRT-1Amnisure International, LLC · 2009
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K081767 | Amnisure Fetal Membranes Rupture Test, Model FMRT-1 | Amnisure International, LLC | 2009 | — |
| +1 | K110605 | Rom Plus | Clinical Innovations, LLC | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110605 | Rom Plus | 2011 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 21, 2020 | Class II | Z-1636-2020 | Employee error | An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute. |
| May 18, 2018 | Class I | Z-2577-2018 | Employee error | Potential for control line not appearing on the test strip |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K110605 (Clinical Innovations, LLC, 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NQM devicesNQM Immunoassay For Detection Of Amniotic Fluid Protein (S).: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NQM
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · NQM
Too few NQM 510(k)s in any year since 2007 to give a median.
Recalls per year · NQM
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQM
1in 2025
MAUDE reports naming product code NQM, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 1 | 5 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Amnisure® ROM (rupture of fetal membrane) Test is a rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal secretion of pregnant women. Amnisure® detects PAMG-1 protein marker of the amniotic fluid in vaginal secretions. The test is for use by health care professionals to aid in the detection of ROM when patients report signs, symptoms or complaints suggestive of ROM.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K081767 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081767: Amnisure Fetal Membranes Rupture Test, Model FMRT-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081767
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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