Cleared Traditional

K810054 - RICA (DIAGNOSTIC INSTRUMENTS)

K810054 is the FDA 510(k) clearance for RICA (DIAGNOSTIC INSTRUMENTS) by Robert I. Chien & Assoc., Inc.. It is a Class 1 Neurology device (product code GWZ) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K810054 · Robert I. Chien & Assoc., Inc. · Neurology device
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Jan 1981
Decision
16d
Days
Class 1
Risk

K810054 is an FDA 510(k) clearance for the RICA (DIAGNOSTIC INSTRUMENTS). Classified as Percussor (product code GWZ), Class I - General Controls.

Submitted by Robert I. Chien & Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1981 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1700 - the FDA neurology 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 Robert I. Chien & Assoc., Inc. devices

Submission Details

510(k) Number K810054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1981
Decision Date January 28, 1981
Days to Decision 16 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
132d faster than avg
Panel avg: 148d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GWZ Percussor
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.1700
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 - GWZ Percussor

All 7
Devices cleared under the same product code (GWZ) and FDA review panel - the closest regulatory comparables to K810054.
OP-CON SURG. INSTRUMENT #10
K834170 · Imm Enterprises , Ltd. · Feb 1984
H.R. JAKOBI SURG. INSTR. #10 34/36
K834178 · Imm Enterprises , Ltd. · Feb 1984
CAT 10-NEUROLOGY DEVICE
K840314 · Imm Enterprises , Ltd. · Feb 1984
CONPHAR PERCUSSION HAMMER(TAYLOR)
K803148 · Conphar, Inc. · Jan 1981
CONPHAR PERCUSSION HAMMER(BUCK TYPE)
K803174 · Conphar, Inc. · Dec 1980