Cleared Traditional

K942960 - PHOSPHATE QVET

K942960 is an FDA 510(k) clearance for PHOSPHATE QVET, manufactured by Prisma Systems. The device is a Class 1 Chemistry device with product code CEO cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K942960 · Prisma Systems · Chemistry device
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Dec 1994
Decision
169d
Days
Class 1
Risk

K942960 is an FDA 510(k) clearance for the PHOSPHATE QVET. Classified as Phosphomolybdate (colorimetric), Inorganic Phosphorus (product code CEO), Class I - General Controls.

Submitted by Prisma Systems (Rome, US). The FDA issued a Cleared decision on December 9, 1994 after a review of 169 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1580 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Prisma Systems devices

FDA 510(k) Submission Details - K942960

510(k) Number K942960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1994
Decision Date December 09, 1994
Days to Decision 169 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 88d · This submission: 169d
Pathway characteristics
Predicate-based equivalence.

CEO Device Classification - Class 1, General Controls

Product Code CEO Phosphomolybdate (colorimetric), Inorganic Phosphorus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1580
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 - CEO Phosphomolybdate (colorimetric), Inorganic Phosphorus

All 77
Devices cleared under the same product code (CEO) and FDA review panel - the closest regulatory comparables to K942960.
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