Cleared Traditional

COUNTWAY SYS. SOILED SPONGES-BLOOD LOS (K830273) - FDA 510(k) Clearance

Class I General Hospital device.

K830273 · Ritmed, Inc. · General Hospital
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Feb 1983
Decision
34d
Days
Class 1
Risk

K830273 is an FDA 510(k) clearance for the COUNTWAY SYS. SOILED SPONGES-BLOOD LOS. Classified as Scale, Surgical Sponge (product code FQA), Class I - General Controls.

Submitted by Ritmed, Inc. (Walker, US). The FDA issued a Cleared decision on February 28, 1983 after a review of 34 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2740 - the FDA general hospital 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.

View all Ritmed, Inc. devices

Submission Details

510(k) Number K830273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1983
Decision Date February 28, 1983
Days to Decision 34 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 129d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FQA Scale, Surgical Sponge
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.2740
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.