Cleared Traditional

K904380 - SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K904380 · Custom Medical Concepts, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
925d
Days
Class 2
Risk

K904380 is an FDA 510(k) clearance for the SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM. Classified as Needle, Spinal, Short Term (product code MIA), Class II - Special Controls.

Submitted by Custom Medical Concepts, Inc. (Chelmsford, US). The FDA issued a Cleared decision on April 8, 1993 after a review of 925 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5150 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Custom Medical Concepts, Inc. devices

Submission Details

510(k) Number K904380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received September 26, 1990
Decision Date April 08, 1993
Days to Decision 925 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
786d slower than avg
Panel avg: 139d · This submission: 925d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MIA Needle, Spinal, Short Term
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.