Cleared Traditional

K771044 - TMA BICARBONATE DILUENT

K771044 is the FDA 510(k) clearance for TMA BICARBONATE DILUENT by Hyland Therapeutic Div., Travenol Laboratories. It is a Class 1 Chemistry device (product code JJS) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K771044 · Hyland Therapeutic Div., Travenol Laboratories · Chemistry device
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Jul 1977
Decision
35d
Days
Class 1
Risk

K771044 is an FDA 510(k) clearance for the TMA BICARBONATE DILUENT. Classified as Controls For Blood-gases, (assayed And Unassayed) (product code JJS), Class I - General Controls.

Submitted by Hyland Therapeutic Div., Travenol Laboratories (Mchenry, US). The FDA issued a Cleared decision on July 15, 1977 after a review of 35 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 Hyland Therapeutic Div., Travenol Laboratories devices

Submission Details

510(k) Number K771044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1977
Decision Date July 15, 1977
Days to Decision 35 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
53d faster than avg
Panel avg: 88d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 43
Devices cleared under the same product code (JJS) and FDA review panel - the closest regulatory comparables to K771044.
CORNING CONFIRM BLOOD GAS QUALITY CONTRO
K792180 · Corning Medical & Scientific · Nov 1979
DYNEX BLOOD GAS QUALITY CONTROL SYS.
K780144 · Analytical Products, Inc. · May 1978
WHOLE BLOOD GAS CONTROL
K770950 · Dade, Baxter Travenol Diagnostics, Inc. · Aug 1977
AQUEOUS PH/BLOOD GAS CONTROLS
K770228 · Instrumentation Laboratory CO · Jun 1977