Cleared Traditional

MV/CM2 NUMBER X74294 MODEL NUMBER 74229 (K837605) - FDA 510(k) Clearance

K837605 · Bio-Tek Instruments, Inc. · Radiology device
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Jun 1983
Decision
43d
Days
-
Risk

K837605 is an FDA 510(k) clearance for the MV/CM2 NUMBER X74294 MODEL NUMBER 74229.

Submitted by Bio-Tek Instruments, Inc. (Winooski, US). The FDA issued a Cleared decision on June 28, 1983 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel. 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 Bio-Tek Instruments, Inc. devices

Submission Details

510(k) Number K837605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1983
Decision Date June 28, 1983
Days to Decision 43 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 107d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -