510(k) · Cleared
ClearedMedicinal Leeches
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
North America BioPharma · NRN Leeches, Medicinal
Cleared on Jun 21, 2004 after a 145-day review. The FDA summary names no predicate by number. 2 later devices descend from it.
- Decided
- Jun 21, 2004
- Review
- 145 days
- Class
- Class U
- Product code
- NRN
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040187 | Medicinal Leeches | North America BioPharma | 2004 | — |
| +1 | K132958 | Medicinal Leeches | North America BioPharma | 2014 | — |
| +1 | K140907 | Leech, Medicinal | Carolina Biological Supply Co. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
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 NRN? 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?
The FDA summary names no predicate by number.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K132958 (North America BioPharma, 2014) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NRN devicesNRN Leeches, Medicinal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NRN
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · NRN
Too few NRN 510(k)s in any year since 2007 to give a median.
Recalls per year · NRN
No recall names NRN since 2007.
Adverse event reports per year · NRN
5in 2025
MAUDE reports naming product code NRN, 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 | 3 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
An adjunct to the healing of graft tissue or to when problems of venots congestion may delay healing, overcome problems of venous congestion by creating prolonged localized bleeding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040187 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040187: Medicinal Leeches.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040187
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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