Cleared Traditional

K924541 - EPIDURAL MINIPACK (FDA 510(k) Clearance)

Class I Anesthesiology device.

K924541 · Concord/Portex · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
304d
Days
Class 1
Risk

K924541 is an FDA 510(k) clearance for the EPIDURAL MINIPACK. Classified as Bottle, Blow (product code BYO), Class I - General Controls.

Submitted by Concord/Portex (Keene, US). The FDA issued a Cleared decision on July 9, 1993 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5220 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Concord/Portex devices

Submission Details

510(k) Number K924541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received September 08, 1992
Decision Date July 09, 1993
Days to Decision 304 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 139d · This submission: 304d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYO Bottle, Blow
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5220
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.