510(k) · Cleared
Recalled · Class II · 2025Romcheck Specimen Collection Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adeza Biomedical · LIO Device, Specimen Collection
Cleared on Feb 2, 1990 after a 16-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 2 times.
- Decided
- Feb 2, 1990
- Review
- 16 days
- Class
- Class I
- Product code
- LIO
- Recalls
- 2
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LIO? 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 LIO device
- #1 K222613 ARX Liquid Amies Collection & Transport Systemscore 8.0 · 4 generations · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 8, 2025 | Class II | Z-1095-2025 | Nonconforming Material/Component | Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen Collection Tubes which may be empty, underfilled, or overfilled with extraction buffer. The transport tubes are used with the Fetal… |
| Dec 15, 2009 | Not classified | Z-1658-2011 | PMA | Product name change requires conversion to a different type of PMA and implies that the product could be used to assess whether a patient's pregnancy is full term, or to predict imminent delivery in women who are at full term gestation. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LIO devicesLIO Device, Specimen Collection: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LIO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LIO
Too few LIO 510(k)s in any year since 2007 to give a median.
Recalls per year · LIO
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LIO
6in 2025
MAUDE reports naming product code LIO, 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 | 8 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 0 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 1 | 3 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K900225 · printed Nov 6, 2026
Cite this page
510(k) Report. “K900225: Romcheck Specimen Collection Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900225
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026