Cleared Traditional

K770351 - METER

K770351 is an FDA 510(k) clearance for METER, manufactured by Beckman Instruments, Inc.. The device is a Class 1 Chemistry device with product code JQY cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K770351 · Beckman Instruments, Inc. · Chemistry device
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Apr 1977
Decision
42d
Days
Class 1
Risk

K770351 is an FDA 510(k) clearance for the METER, IV PH, MODEL ZEROMATIC. Classified as Ph Meter (product code JQY), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 5, 1977 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2050 - 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 - K770351

510(k) Number K770351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1977
Decision Date April 05, 1977
Days to Decision 42 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
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

JQY Device Classification - Class 1, General Controls

Product Code JQY Ph Meter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2050
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 - JQY Ph Meter

Devices cleared under the same product code (JQY) and FDA review panel - the closest regulatory comparables to K770351.
CIBA CORNING 288 PH/BLOOD GAS SYSTEM
K872888 · Ciba Corning Diagnostics Corp. · Aug 1987
METER, PH, DIGITAL, MODEL 3560
K770347 · Beckman Instruments, Inc. · Apr 1977
METER, IV PH, MODEL EXPANDOMATIC
K770352 · Beckman Instruments, Inc. · Apr 1977
PH METER-125 (.01 PH)
K760788 · Corning Medical & Scientific · Nov 1976
PH METER-130 (.001 PH)
K760789 · Corning Medical & Scientific · Nov 1976