Cleared Traditional

K810618 - AMPULED FLAME PHOTOMETER STANDARDS

K810618 is an FDA 510(k) clearance for AMPULED FLAME PHOTOMETER STANDARDS, manufactured by United Diagnostics, Inc.. The device is a Class 2 Radiology device with product code JIS cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K810618 · United Diagnostics, Inc. · Radiology device
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Mar 1981
Decision
22d
Days
Class 2
Risk

K810618 is an FDA 510(k) clearance for the AMPULED FLAME PHOTOMETER STANDARDS. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by United Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 31, 1981 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 862.1150 - the FDA radiology and imaging software oversight 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 United Diagnostics, Inc. devices

FDA 510(k) Submission Details - K810618

510(k) Number K810618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1981
Decision Date March 31, 1981
Days to Decision 22 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 107d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIS Device Classification - Class 2, Special Controls

Product Code JIS Calibrator, Primary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 Radiology devices follow this clearance model.

Regulatory Peers - JIS Calibrator, Primary

All 113
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K810618.
CHOLESTEROL CALIBRATORS
K812861 · Gilford Diagnostics · Oct 1981
BIO SET TM SUBSTRATE CALIBRATORS
K810963 · Boehringer Mannheim Corp. · Apr 1981
FOLLICLE STIMULATING HORMONE (FSH)
K810867 · Pcl-Ria, Inc. · Apr 1981
AQUEOUS TRIOLEIN STANDARDS & KITS
K810742 · Supelco, Inc. · Mar 1981
LECITHIN-SPINGOMYELIN STAND. & KITS
K810743 · Supelco, Inc. · Mar 1981
EMIT-TFG PRISMA THYROXINE CALIBRATORS
K810587 · Syva Co. · Mar 1981