Cleared Traditional

K963992 - CAPILLARY ADAPTOR ACCESSORY

K963992 is an FDA 510(k) clearance for CAPILLARY ADAPTOR ACCESSORY, manufactured by Medica Corp.. The device is a Class 2 Toxicology device with product code CGZ cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K963992 · Medica Corp. · Toxicology device
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Nov 1996
Decision
56d
Days
Class 2
Risk

K963992 is an FDA 510(k) clearance for the CAPILLARY ADAPTOR ACCESSORY. Classified as Electrode, Ion-specific, Chloride (product code CGZ), Class II - Special Controls.

Submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on November 29, 1996 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1170 - the FDA toxicology 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 Medica Corp. devices

FDA 510(k) Submission Details - K963992

510(k) Number K963992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1996
Decision Date November 29, 1996
Days to Decision 56 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 87d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGZ Device Classification - Class 2, Special Controls

Product Code CGZ Electrode, Ion-specific, Chloride
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1170
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 Toxicology devices follow this clearance model.

Regulatory Peers - CGZ Electrode, Ion-specific, Chloride

All 34
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