Cleared Traditional

K841181 - ASTRA SYS INORGANIC PHOSPHORUS CHEM

K841181 is an FDA 510(k) clearance for ASTRA SYS INORGANIC PHOSPHORUS CHEM, manufactured by Beckman Instruments, Inc.. The device is a Class 1 Chemistry device with product code CEO cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K841181 · Beckman Instruments, Inc. · Chemistry device
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May 1984
Decision
50d
Days
Class 1
Risk

K841181 is an FDA 510(k) clearance for the ASTRA SYS INORGANIC PHOSPHORUS CHEM. Classified as Phosphomolybdate (colorimetric), Inorganic Phosphorus (product code CEO), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1984 after a review of 50 days - a notably fast clearance 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: 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K841181

510(k) Number K841181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1984
Decision Date May 09, 1984
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 88d · This submission: 50d
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 K841181.
INORGANIC PHOSPHORUS TEST
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K843030 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1984
PHOPHORUS REAGNET SET
K841061 · Medical Specialties, Inc. · May 1984
PHOSPHORUS REAGENT SYSTEM
K840215 · Sclavo, Inc. · Mar 1984
PARAMAX PHOSPHORUS REAGENT
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