Cleared Traditional

K843435 - LABMASTER & CRSI 600

K843435 is an FDA 510(k) clearance for LABMASTER & CRSI 600, manufactured by Control Resource Systems, Inc.. The device is a Class 2 General Hospital device with product code FRF cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K843435 · Control Resource Systems, Inc. · General Hospital
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May 1985
Decision
253d
Days
Class 2
Risk

K843435 is an FDA 510(k) clearance for the LABMASTER & CRSI 600. Classified as Cleaner, Air, Medical Recirculating (product code FRF), Class II - Special Controls.

Submitted by Control Resource Systems, Inc. (Walker, US). The FDA issued a Cleared decision on May 15, 1985 after a review of 253 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5045 - the FDA general hospital 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Control Resource Systems, Inc. devices

FDA 510(k) Submission Details - K843435

510(k) Number K843435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1984
Decision Date May 15, 1985
Days to Decision 253 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 129d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRF Device Classification - Class 2, Special Controls

Product Code FRF Cleaner, Air, Medical Recirculating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5045
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 General Hospital devices follow this clearance model.

Regulatory Peers - FRF Cleaner, Air, Medical Recirculating

All 23
Devices cleared under the same product code (FRF) and FDA review panel - the closest regulatory comparables to K843435.
MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAP
K974682 · Biological Controls, Inc. · Jan 1998
HEPA-TYPE AIR CLEANER MODEL 2586 AND TRUE HEPA AIR CLEANER MODELS 2587 AND 2588
K960966 · Sunbeam-Oster Household Products · Jan 1997
NORELCO CLEAN AIR SYSTEM CAS950
K945161 · Hogan & Hartson · Nov 1994
FILTER, PARTICULATE ARRESTING
K760481 · Miles Laboratories, Inc. · Sep 1976