510(k) · Cleared

Cleared

Medicinal Leeches

K132958510(k) TraditionalCleared Feb 19, 2014152-day reviewClass U

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

North America BioPharma · NRN Leeches, Medicinal

Cleared on Feb 19, 2014 as substantially equivalent to K040187 (North America BioPharma, 2004) after a 152-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it.

Decided: Feb 19, 2014
Review: 152 days
Class: Class U
Product code: NRN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K040187 (2004). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK040187 Medicinal LeechesNorth America BioPharma · 2004
This deviceK132958 Medicinal LeechesNorth America BioPharma · 2014
Descendant · cites it directly · 0 of its ownK140907 Leech, MedicinalCarolina Biological Supply Co. · 2015

Most influential descendants

Showing 1 of 1 · See all

K140907Leech, MedicinalCarolina Biological Supply Co. · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K040187	Medicinal Leeches	North America BioPharma	2004	—
0 (this device)	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
2015	1	0

FIG. 1 — Lineage of K132958, 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? (1)

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 2 …venous circulation. Leeches can be used to alleviate the problem of venious congestion by creating prolonged localized bleeding. 7. Predicate Device 51 0(k) number: K040187 - Trade name: Medicinal Leeches 8. Summary of the Characteristics of Our Device Compared to Its Predicate Our device and its…	North America BioPharma	2004	—

Also cleared against K040187: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K140907	Leech, Medicinal	Carolina Biological Supply Co.	2015	0

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?

Its one ancestor has no recall.
Of its descendants, K140907 (Carolina Biological Supply Co., 2015) has gone furthest, with 0 descendants of its own.
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. 2014, 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?

Leeches may be used in instances where skin flaps, skin graft, or other tissues are suffering from impaired venous circulation. Leeches may be used to alleviate the problem of venous congestion by creating prolonged localized bleeding.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K132958 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132958: Medicinal Leeches.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132958

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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