Cleared Traditional

K924373 - ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMP (FDA 510(k) Clearance)

Class I Anesthesiology device.

K924373 · Instrumed, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
89d
Days
Class 1
Risk

K924373 is an FDA 510(k) clearance for the ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMP. Classified as Cart, Emergency, Cardiopulmonary (excluding Equipment) (product code BZN), Class I - General Controls.

Submitted by Instrumed, Inc. (Bothell, US). The FDA issued a Cleared decision on November 25, 1992 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6175 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Instrumed, Inc. devices

Submission Details

510(k) Number K924373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1992
Decision Date November 25, 1992
Days to Decision 89 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 139d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BZN Cart, Emergency, Cardiopulmonary (excluding Equipment)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.6175
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.