510(k) · Cleared

Cleared

Leech, Medicinal

K140907510(k) TraditionalCleared Aug 7, 2015486-day reviewClass U

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

Carolina Biological Supply Co. · NRN Leeches, Medicinal

Cleared on Aug 7, 2015 as substantially equivalent to K040187 (North America BioPharma, 2004) and 1 other predicate after a 486-day review. Its family tree reaches back 2 generations to 2004.

Decided: Aug 7, 2015
Review: 486 days
Class: Class U
Product code: NRN
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K040187 (2004). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK040187 Medicinal LeechesNorth America BioPharma · 2004
1 generation backK132958 Medicinal LeechesNorth America BioPharma · 2014
This deviceK140907 Leech, MedicinalCarolina Biological Supply Co. · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K040187	Medicinal Leeches	North America BioPharma	2004	—
−1	K132958	Medicinal Leeches	North America BioPharma	2014	—
0 (this device)	K140907	Leech, Medicinal	Carolina Biological Supply Co.	2015	—

FIG. 1 — Lineage of K140907, 2004–2015Source: 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 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

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What was it cleared against? (2)

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
*	K040187	Medicinal Leeches Summary page 4 …cation: Unclassified Equivalent Legally Marketed Product 510(K) MANUFACTURER PRODUCT DATE K040187 Ricarimpex SAS Medicinal Leeches (Hirudo Medicinalis) 06-21-04 K132958 Biopharm (UK) Ltd European…	North America BioPharma	2004	—
*	K132958	Medicinal Leeches Summary page 4 …R PRODUCT DATE K040187 Ricarimpex SAS Medicinal Leeches (Hirudo Medicinalis) 06-21-04 K132958 Biopharm (UK) Ltd European Medicinal Leeches (Hirudo Verbena) 02-19-14 Product Description The Medicinal Leec…	North America BioPharma	2014	—

Also cleared against K040187: 1 other device →

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.

What does this lineage say?

The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 9.7 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K040187.

How does its category compare?

All NRN devices

NRN Leeches, Medicinal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · NRN

1in 2015

2007high 1 (2014) · low 0 (2007)2026

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

2007high 5 (2024) · low 0 (2007)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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	3
2013	0	—	2
2014	1	—	0
2015	1	—	4
2016	0	—	4
2017	0	—	2
2018	0	—	4
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	4
2024	0	—	5
2025	0	—	5
2026	0	—	—

What is it indicated for?

Medicinal leeches may be used in instances where skin flaps, skin grafts, surgical reattachments, or other tissues are adversely affected by impaired venous blood flow. Leeches may be used to alleviate the problem of venous congestion and delayed healing by creating prolonged localized bleeding.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K140907 · printed Nov 4, 2026

Cite this page

510(k) Report. “K140907: Leech, Medicinal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140907

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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