Cleared Traditional

K791200 - PRE-DENT

K791200 is an FDA 510(k) clearance for PRE-DENT, manufactured by Fichte, Graves, and Hunt. The device is a Class 2 Chemistry device with product code GIM cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K791200 · Fichte, Graves, and Hunt · Chemistry device
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Aug 1979
Decision
43d
Days
Class 2
Risk

K791200 is an FDA 510(k) clearance for the PRE-DENT. Classified as Tubes, Vacuum Sample, With Anticoagulant (product code GIM), Class II - Special Controls.

Submitted by Fichte, Graves, and Hunt (Mchenry, US). The FDA issued a Cleared decision on August 10, 1979 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - 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 Fichte, Graves, and Hunt devices

FDA 510(k) Submission Details - K791200

510(k) Number K791200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1979
Decision Date August 10, 1979
Days to Decision 43 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 88d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GIM Device Classification - Class 2, Special Controls

Product Code GIM Tubes, Vacuum Sample, With Anticoagulant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
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 - GIM Tubes, Vacuum Sample, With Anticoagulant

All 30
Devices cleared under the same product code (GIM) and FDA review panel - the closest regulatory comparables to K791200.
QS90 SMOOTH E ARTERIAL BLOOD SAMPLER
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ACCUFIBRIN(TM) BLOOD COLLECTION SYSTEM AF100
K882501 · Terumo Medical Corp. · Jul 1988
VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE)
K861449 · Exel Intl. · Sep 1986
J-VAC VACUUM TUBE
K771874 · Jelco Laboratories · Dec 1977
LIQUAEMIB SODIUM PRESERVATIVE, ETC.
K771304 · Organon, Inc. · Aug 1977
LIQUAEMIN SODIUM, HEPARIN SODIUM ETC.
K771305 · Organon, Inc. · Aug 1977