Cleared Traditional

K791287 - MEDICOR QUALITY CONTROL BUFFER

K791287 is an FDA 510(k) clearance for MEDICOR QUALITY CONTROL BUFFER, manufactured by Medicor USA , Ltd.. The device is a Class 1 Chemistry device with product code JJS cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K791287 · Medicor USA , Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1979
Decision
37d
Days
Class 1
Risk

K791287 is an FDA 510(k) clearance for the MEDICOR QUALITY CONTROL BUFFER. Classified as Controls For Blood-gases, (assayed And Unassayed) (product code JJS), Class I - General Controls.

Submitted by Medicor USA , Ltd. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1979 after a review of 37 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 Medicor USA , Ltd. devices

FDA 510(k) Submission Details - K791287

510(k) Number K791287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1979
Decision Date August 16, 1979
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 88d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

JJS Device Classification - Class 1, General Controls

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 59
Devices cleared under the same product code (JJS) and FDA review panel - the closest regulatory comparables to K791287.
REFEREE BFT BLOOD FOR TONOMETRY
K792447 · Analytical Products, Inc. · Dec 1979
FISHER DIAG. PRIME BLOOD GAS CONTROLS
K792143 · Fisher Scientific Co., LLC · Nov 1979
CORNING CONFIRM BLOOD GAS QUALITY CONTRO
K792180 · Corning Medical & Scientific · Nov 1979
MULTECON BLOOD GAS CONTROL
K790813 · Ortho Diagnostics, Inc. · Jun 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