Cleared Traditional

K771253 - HEMOX-ANALYZER

K771253 is an FDA 510(k) clearance for HEMOX-ANALYZER, manufactured by 3M Company. The device is a Class 2 Chemistry device with product code CHL cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K771253 · 3M Company · Chemistry device
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Aug 1977
Decision
45d
Days
Class 2
Risk

K771253 is an FDA 510(k) clearance for the HEMOX-ANALYZER. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by 3M Company (White City, US). The FDA issued a Cleared decision on August 25, 1977 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1120 - 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 3M Company devices

FDA 510(k) Submission Details - K771253

510(k) Number K771253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1977
Decision Date August 25, 1977
Days to Decision 45 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
43d faster than avg
Panel avg: 88d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CHL Device Classification - Class 2, Special Controls

Product Code CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1120
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 - CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

All 159
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K771253.
TECHNICON BGII ANALYZER
K780716 · Technicon Instruments Corp. · Jun 1978
PCO 2 ELECTROLYTE
K772307 · Fisher Scientific Co., LLC · Dec 1977
BG II ANALYZER
K771822 · Technicon Instruments Corp. · Oct 1977
MONITOR, PATIENT, MODEL PM-20N
K770736 · Cavitron Corp. · Jun 1977
PH/BLOOD GAS SYSTEM
K760969 · Instrumentation Laboratory CO · Jan 1977