Cleared Traditional

TENS MAX (K823388) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K823388 · Fujisawa Electronics Co. · Hematology device
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Jan 1983
Decision
54d
Days
Class 2
Risk

K823388 is an FDA 510(k) clearance for the TENS MAX. Classified as Fibrinogen Determination Standards And Controls (product code GFK), Class II - Special Controls.

Submitted by Fujisawa Electronics Co. (Mchenry, US). The FDA issued a Cleared decision on January 8, 1983 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7340 - 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.

View all Fujisawa Electronics Co. devices

Submission Details

510(k) Number K823388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1982
Decision Date January 08, 1983
Days to Decision 54 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 113d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GFK Fibrinogen Determination Standards And Controls
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.