Cleared Traditional

K822039 - BECKMAN ASTRA

K822039 is an FDA 510(k) clearance for BECKMAN ASTRA, manufactured by Beckman Instruments, Inc.. The device is a Class 2 Chemistry device with product code JGS cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K822039 · Beckman Instruments, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1982
Decision
101d
Days
Class 2
Risk

K822039 is an FDA 510(k) clearance for the BECKMAN ASTRA. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 21, 1982 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1665 - 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K822039

510(k) Number K822039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1982
Decision Date October 21, 1982
Days to Decision 101 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
13d slower than avg
Panel avg: 88d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JGS Device Classification - Class 2, Special Controls

Product Code JGS Electrode, Ion Specific, Sodium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1665
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 Chemistry devices follow this clearance model.

Regulatory Peers - JGS Electrode, Ion Specific, Sodium

All 116
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K822039.
AMRESCO NA/K REAGENT SET
K832070 · American Research Products Co. · Aug 1983
POTASSIUM ANALYZER-SODIUM/ELECTROLYTE
K830588 · Shaban Mfg. Co. · Apr 1983
ELECTROLYTE STANDARD - CORNING NALK ISE
K830589 · Shaban Mfg. Co. · Apr 1983
LIQUIZYME NA+/K+ REAGENT SET
K820395 · American Research Products Co. · Mar 1982
IL 501, NA/K ANALYZER
K812762 · Instrumentation Laboratory CO · Oct 1981
902 NA/K
K811896 · Corning Medical & Scientific · Jul 1981