Cleared Traditional

K852554 - SRT-SYSTEM

K852554 is an FDA 510(k) clearance for SRT-SYSTEM, manufactured by Microwave Development, Inc.. The device is a Class 1 Hematology device with product code JPH cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K852554 · Microwave Development, Inc. · Hematology device
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Jul 1985
Decision
31d
Days
Class 1
Risk

K852554 is an FDA 510(k) clearance for the SRT-SYSTEM. Classified as Test, Erythrocyte Sedimentation Rate (product code JPH), Class I - General Controls.

Submitted by Microwave Development, Inc. (Old Greenwich, US). The FDA issued a Cleared decision on July 18, 1985 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6700 - the FDA hematology device 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.

FDA 510(k) Submission Details - K852554

510(k) Number K852554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1985
Decision Date July 18, 1985
Days to Decision 31 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 113d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

JPH Device Classification - Class 1, General Controls

Product Code JPH Test, Erythrocyte Sedimentation Rate
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.6700
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 - JPH Test, Erythrocyte Sedimentation Rate

Devices cleared under the same product code (JPH) and FDA review panel - the closest regulatory comparables to K852554.
WINPETTE
K871076 · Ulster Scientific, Inc. · Mar 1987
DISPETTE II
K860899 · Ulster Scientific, Inc. · Apr 1986
SEDIPLAST
K840500 · Precision Technology, Inc. · Feb 1984
WESTERGREN DISPETTE FOR ESR
K831195 · Ulster Scientific, Inc. · May 1983
ERYTHROCYTE & STAND SEDIMENT. RATE TUBE
K823761 · Cordis Corp. · Jan 1983
DADE ESR KIT
K823368 · American Dade · Dec 1982
K852554 · SRT-SYSTEM
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