510(k) · Cleared

Cleared

Flexible Introducer Cannula, Model 135-1837

K051860510(k) TraditionalCleared Aug 22, 200545-day reviewClass II21 CFR 868.5150

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

Epimed International, Inc. · MIA Needle, Spinal, Short Term

Cleared on Aug 22, 2005 as substantially equivalent to K904380 (Custom Medical Concepts, Inc., 1993) after a 45-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.

Decided: Aug 22, 2005
Review: 45 days
Class: Class II
Product code: MIA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K904380 (1993). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK904380 Spinal Cord Access Epidural Introducer SystemCustom Medical Concepts, Inc. · 1993
This deviceK051860 Flexible Introducer Cannula, Model 135-1837Epimed International, Inc. · 2005
Descendant · cites it directly · 0 of its ownK200624 Percutaneous IntroducerEpimed International, Inc. · 2020

Most influential descendants

Showing 1 of 1 · See all

K200624Percutaneous IntroducerEpimed International, Inc. · 2020 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K904380	Spinal Cord Access Epidural Introducer System	Custom Medical Concepts, Inc.	1993	—
0 (this device)	K051860	Flexible Introducer Cannula, Model 135-1837	Epimed International, Inc.	2005	—
+1	K200624	Percutaneous Introducer	Epimed International, Inc.	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	1	0

FIG. 1 — Lineage of K051860, 1993–2020Source: 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 MIA? 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
*	K904380	Spinal Cord Access Epidural Introducer System Summary page 1 …roduct Class/Classification: Class II - MIA, 21 CFR 868.5150 Predicate Device(s): Custom Medical Concepts Spinal Cord Access Epidural Introducer System (K904380) Description: The Flexible Introducer Cannula consists of a plastic cannula with a molded plastic hub. The device is…	Custom Medical Concepts, Inc.	1993	—

Also cleared against K904380: 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
K200624	Percutaneous Introducer	Epimed International, Inc.	2020	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, K200624 (Epimed International, Inc., 2020) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K904380.

How does its category compare?

All MIA devices

MIA Needle, Spinal, Short Term: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MIA

1in 2018

2007high 1 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MIA

Too few MIA 510(k)s in any year since 2007 to give a median.

Recalls per year · MIA

No recall names MIA since 2007.

Adverse event reports per year · MIA

14in 2025

2007high 23 (2016) · low 0 (2011)2025

MAUDE reports naming product code MIA, 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	—	5
2008	0	—	6
2009	0	—	4
2010	0	—	1
2011	0	—	0
2012	0	—	3
2013	0	—	2
2014	0	—	4
2015	0	—	12
2016	0	—	23
2017	0	—	15
2018	1	—	14
2019	0	—	9
2020	0	—	5
2021	0	—	4
2022	0	—	19
2023	0	—	12
2024	0	—	23
2025	0	—	14
2026	0	—	—

What is it indicated for?

The Flexible Introducer Cannula is intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051860 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051860: Flexible Introducer Cannula, Model 135-1837.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051860

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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