Cleared Traditional

IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO- (K830149) - FDA 510(k) Clearance

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

K830149 · Instrumentation Laboratory CO · Chemistry device
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Feb 1983
Decision
42d
Days
Class 2
Risk

K830149 is an FDA 510(k) clearance for the IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO-. Classified as Suction Control, Intracardiac, Cardiopulmonary Bypass (product code DWD), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on February 28, 1983 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 870.4430 - the FDA in vitro diagnostics and chemistry 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 Instrumentation Laboratory CO devices

Submission Details

510(k) Number K830149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1983
Decision Date February 28, 1983
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWD Suction Control, Intracardiac, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4430
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 Chemistry devices follow this clearance model.

Regulatory Peers - DWD Suction Control, Intracardiac, Cardiopulmonary Bypass

All 14
Devices cleared under the same product code (DWD) and FDA review panel - the closest regulatory comparables to K830149.
B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT.
K915480 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1992
B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT
K915481 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1992
B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT
K915482 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1992