Cleared Traditional

K810588 - SYNCHRONIZER #208 (FDA 510(k) Clearance)

Class I Radiology device.

K810588 · Brattle Instrument Corp. · Radiology device
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Apr 1981
Decision
37d
Days
Class 1
Risk

K810588 is an FDA 510(k) clearance for the SYNCHRONIZER #208. Classified as Synchronizer, Ecg / Respirator, Radiographic (product code IXO), Class I - General Controls.

Submitted by Brattle Instrument Corp. (Mchenry, US). The FDA issued a Cleared decision on April 10, 1981 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1970 - 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 Brattle Instrument Corp. devices

Submission Details

510(k) Number K810588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1981
Decision Date April 10, 1981
Days to Decision 37 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 107d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IXO Synchronizer, Ecg / Respirator, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1970
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.