Cleared Traditional

CLINICAL CARE STIMULATOR (K840725) - FDA 510(k) Clearance

K840725 · Biostim, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1984
Decision
57d
Days
-
Risk

K840725 is an FDA 510(k) clearance for the CLINICAL CARE STIMULATOR.

Submitted by Biostim, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 18, 1984 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Neurology 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 Biostim, Inc. devices

Submission Details

510(k) Number K840725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1984
Decision Date April 18, 1984
Days to Decision 57 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 148d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -