Cleared Traditional

K830898 - SYRINGE 500BC BE #7000 (FDA 510(k) Clearance)

Class I Anesthesiology device.

K830898 · Instrumentation Industries, Inc. · Anesthesiology device
May 1983
Decision
56d
Days
Class 1
Risk

K830898 is an FDA 510(k) clearance for the SYRINGE 500BC BE #7000. Classified as Calibrator, Volume, Gas (product code BXW), Class I - General Controls.

Submitted by Instrumentation Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 16, 1983 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1870 - 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.

Submission Details

510(k) Number K830898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1983
Decision Date May 16, 1983
Days to Decision 56 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Regulatory Context
Review time vs. panel average
169d faster than avg
Panel avg: 225d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BXW Calibrator, Volume, Gas
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.1870
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.