Cleared Traditional

K955850 - PRO-TECH

K955850 is an FDA 510(k) clearance for PRO-TECH, manufactured by Central Solutions, Inc.. The device is a Class 1 General Hospital device with product code LRJ cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K955850 · Central Solutions, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
44d
Days
Class 1
Risk

K955850 is an FDA 510(k) clearance for the PRO-TECH. Classified as Disinfectant, Medical Devices (product code LRJ), Class I - General Controls.

Submitted by Central Solutions, Inc. (Kansas City, US). The FDA issued a Cleared decision on February 9, 1996 after a review of 44 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6890 - 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: 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 Central Solutions, Inc. devices

FDA 510(k) Submission Details - K955850

510(k) Number K955850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1995
Decision Date February 09, 1996
Days to Decision 44 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 129d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

LRJ Device Classification - Class 1, General Controls

Product Code LRJ Disinfectant, Medical Devices
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6890
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.

Regulatory Peers - LRJ Disinfectant, Medical Devices

All 31
Devices cleared under the same product code (LRJ) and FDA review panel - the closest regulatory comparables to K955850.
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T.B.Q.
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KLORMAN
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VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT
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