Cleared Traditional

K894490 - STERILE ULTRASOUND TRANSMISSION GEL

K894490 is an FDA 510(k) clearance for STERILE ULTRASOUND TRANSMISSION GEL, manufactured by Swedish Trade Council USA. The device is a Class 2 General & Plastic Surgery device with product code JOT cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K894490 · Swedish Trade Council USA · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1989
Decision
79d
Days
Class 2
Risk

K894490 is an FDA 510(k) clearance for the STERILE ULTRASOUND TRANSMISSION GEL. Classified as Electrode, Gel, Electrosurgical (product code JOT), Class II - Special Controls.

Submitted by Swedish Trade Council USA (Chicago, US). The FDA issued a Cleared decision on October 5, 1989 after a review of 79 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery 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 Swedish Trade Council USA devices

FDA 510(k) Submission Details - K894490

510(k) Number K894490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1989
Decision Date October 05, 1989
Days to Decision 79 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOT Device Classification - Class 2, Special Controls

Product Code JOT Electrode, Gel, Electrosurgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 General & Plastic Surgery devices follow this clearance model.