Cleared Traditional

K771700 - TMA BICARBONATE/GLYCEROL DILUENT (FDA 510(k) Clearance)

K771700 · Hyland Therapeutic Div., Travenol Laboratories · Chemistry device
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Nov 1977
Decision
65d
Days
-
Risk

K771700 is an FDA 510(k) clearance for the TMA BICARBONATE/GLYCEROL DILUENT.

Submitted by Hyland Therapeutic Div., Travenol Laboratories (Mchenry, US). The FDA issued a Cleared decision on November 11, 1977 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel. 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 K771700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1977
Decision Date November 11, 1977
Days to Decision 65 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 88d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -