Cleared Traditional

K830149 - IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO-

K830149 is an FDA 510(k) clearance for IL VIDEO 22, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Chemistry device with product code DWD cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K830149 · Instrumentation Laboratory CO · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K830149

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
Combination Product No
PCCP Authorized No
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.

DWD Device Classification - Class 2, Special Controls

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 12
Devices cleared under the same product code (DWD) and FDA review panel - the closest regulatory comparables to K830149.
LEFT VENTRICULAR VENT VALVE MODEL NO. GLV
K862540 · Gish Biomedical, Inc. · Aug 1986
SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100
K861428 · American Omni Medical, Inc. · Jun 1986
AJDJUSTABLE SUCTION CONTROL VALVE
K851406 · American Omni Medical, Inc. · Aug 1985
VEINPREP VEIN GRAFT PREP. KIT A277723
K830150 · Atrium Medical Corp. · Feb 1983
VACUUM RELIEF VALVE
K760894 · Delta Medical Industries · Dec 1976