Cleared Traditional

K931608 - NCA-200

K931608 is an FDA 510(k) clearance for NCA-200, manufactured by Ics Medical Corp.. The device is a Class 1 Ear, Nose, Throat device with product code KHH cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K931608 · Ics Medical Corp. · Ear, Nose, Throat device
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Jun 1993
Decision
82d
Days
Class 1
Risk

K931608 is an FDA 510(k) clearance for the NCA-200. Classified as Stimulator, Caloric-air (product code KHH), Class I - General Controls.

Submitted by Ics Medical Corp. (Schaumburg, US). The FDA issued a Cleared decision on June 22, 1993 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1800 - the FDA ear, nose and throat 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.

FDA 510(k) Submission Details - K931608

510(k) Number K931608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1993
Decision Date June 22, 1993
Days to Decision 82 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 90d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

KHH Device Classification - Class 1, General Controls

Product Code KHH Stimulator, Caloric-air
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.1800
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 - KHH Stimulator, Caloric-air

Devices cleared under the same product code (KHH) and FDA review panel - the closest regulatory comparables to K931608.
HORTMANN AIRMATIC AIR CALORIC STIMULATOR
K950785 · Jedmed Instrument Co. · Jun 1995
EAR-A-GATOR
K946108 · Life-Tech Intl., Inc. · Jun 1995
WATER IRRIGATOR, W1 200
K941325 · Strong Medical, Inc. · Aug 1994
AUTOMATIC CALORIC IRRIGATION SYSTEM
K925237 · Ics Medical Corp. · May 1993
AUTOMATIC CALORIC IRRIGATION SYSTEM
K881630 · Ics Medical Corp. · Jun 1988
FRENZEL EYEGLASSES & RELATED ITEMS
K822179 · Kelleher Corp. · Sep 1982
K931608 · NCA-200
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