Cleared Traditional

K820103 - PATHWAY PH BLOOD GAS CONTROL

K820103 is an FDA 510(k) clearance for PATHWAY PH BLOOD GAS CONTROL, manufactured by Beckman Instruments, Inc.. The device is a Class 1 Chemistry device with product code JJS cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K820103 · Beckman Instruments, Inc. · Chemistry device
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Jan 1982
Decision
13d
Days
Class 1
Risk

K820103 is an FDA 510(k) clearance for the PATHWAY PH BLOOD GAS CONTROL. Classified as Controls For Blood-gases, (assayed And Unassayed) (product code JJS), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1982 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 - K820103

510(k) Number K820103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1982
Decision Date January 28, 1982
Days to Decision 13 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
75d faster than avg
Panel avg: 88d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

JJS Device Classification - Class 1, General Controls

Product Code JJS Controls For Blood-gases, (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJS Controls For Blood-gases, (assayed And Unassayed)

All 48
Devices cleared under the same product code (JJS) and FDA review panel - the closest regulatory comparables to K820103.
REFEREE BLOOD GAS ANALYZER CONTROLS
K830181 · Analytical Products, Inc. · Feb 1983
CORNING CERTAIN TM
K820873 · Corning Medical & Scientific · Apr 1982
FETAL-TEK CONTROL MATURE
K820319 · Helena Laboratories · Mar 1982
PROTEIN-BASED BLOOD GAS CONTROL
K812541 · American Dade · Sep 1981
AQUEOUS BLOOD GAS CONTROLS
K812553 · Fisher Scientific Co., LLC · Sep 1981
PH/BLOOD GAS CONTROL (ABC)
K811143 · Instrumentation Laboratory CO · May 1981