510(k) Report

510(k) · Decided

Decided

Spinal Cord Access Epidural Introducer System

K904380510(k) TraditionalDecided Apr 8, 1993925-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

Custom Medical Concepts, Inc. · MIA Needle, Spinal, Short Term

Cleared on Apr 8, 1993 after a 925-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Apr 8, 1993
Review
925 days
Class
Class II
Product code
MIA
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2005: 2 descendants cleared2020: 1 descendant cleared1990200020102020
  1. This deviceK904380 Spinal Cord Access Epidural Introducer SystemCustom Medical Concepts, Inc. · 1993
  2. Descendant · cites it directly · 1 of its ownK051860 Flexible Introducer Cannula, Model 135-1837Epimed International, Inc. · 2005
  3. Descendant · 2 generations on · 0 of its ownK200624 Percutaneous IntroducerEpimed International, Inc. · 2020
  4. Descendant · cites it directly · 0 of its ownK043467 Flexible Spinal NeedleEpimed International, Inc. · 2005

Most influential descendants

Showing 3 of 3 · See all
  • K051860Flexible Introducer Cannula, Model 135-1837Epimed International, Inc. · 2005 · cites it directly1descendant
  • K200624Percutaneous IntroducerEpimed International, Inc. · 2020 · 2 generations on0descendants
  • K043467Flexible Spinal NeedleEpimed International, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K904380Spinal Cord Access Epidural Introducer SystemCustom Medical Concepts, Inc.1993—
+1K051860Flexible Introducer Cannula, Model 135-1837Epimed International, Inc.2005—
+2K200624Percutaneous IntroducerEpimed International, Inc.2020—
+1K043467Flexible Spinal NeedleEpimed International, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
202010
FIG. 1 — Lineage of K904380, 1993–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K051860Flexible Introducer Cannula, Model 135-1837Epimed International, Inc.20051
K043467Flexible Spinal NeedleEpimed International, Inc.20050

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, K051860 (Epimed International, Inc., 2005) has gone furthest, with 1 descendant of its own.

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

2018: 1
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

2007: 52008: 62009: 42010: 12012: 32013: 22014: 42015: 122016: 232017: 152018: 142019: 92020: 52021: 42022: 192023: 122024: 232025: 14
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—05
20080—06
20090—04
20100—01
20110—00
20120—03
20130—02
20140—04
20150—012
20160—023
20170—015
20181—014
20190—09
20200—05
20210—04
20220—019
20230—012
20240—023
20250—014
20260—0—

Recent decisions in MIA

The MIA category page

  • K172800Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™…Smiths Medical Asd, Inc. · 2018
  • K051860Flexible Introducer Cannula, Model 135-1837Epimed International, Inc. · 2005
  • K983858Spinal Anesthesia Needles and Introducer NeedlesSims Portex, Inc. · 1999
  • K982269Clear Hub Spinal Needle 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA and 27GAAllegiance Healthcare Corp. · 1998
  • K971645Reganes Spinal Needle (Various)Avid N.I.T., Inc. · 1997

https://510kreport.com/device/K904380 · printed Nov 6, 2026

Cite this page

510(k) Report. “K904380: Spinal Cord Access Epidural Introducer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K904380

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026