510(k) · Cleared
ClearedFetal D Tection Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biopool Intl., Inc. · LIM Test, Screening, For D Positive Fetal Rbc'S
Cleared on Apr 8, 1998 after a 71-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 8, 1998
- Review
- 71 days
- Class
- Class II
- Product code
- LIM
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
Planning a device in LIM? 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?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All LIM devicesLIM Test, Screening, For D Positive Fetal Rbc'S: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LIM
FDA has decided no LIM device since 2007.
Median 510(k) review, days · LIM
Too few LIM 510(k)s in any year since 2007 to give a median.
Recalls per year · LIM
No recall names LIM since 2007.
Adverse event reports per year · LIM
1in 2024
MAUDE reports naming product code LIM, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Fetal D Tection Kit is indicated for use to test blood samples drawn from D negative mothers who have delivered D positive infants. The blood sample should be drawn shortly after all products of conception have been delivered, and then assayed as soon as possible, since RhIg should be administered to the mother within 72 hours of delivery to be effective. Positive result in this qualitative test indicates the need to perform a quantitative test to determine if more than one 300 mg dose of RhIg will adequately protect the mother from being sensitized to the D antigen.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980314 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980314: Fetal D Tection Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980314
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026