K870762 is an FDA 510(k) clearance for EAR APPLICATOR, manufactured by Treace Medical, Inc.. The device is a Class 1 General Hospital device with product code KXF cleared through the Traditional 510(k) pathway after a 8-day FDA review.
K870762 is an FDA 510(k) clearance for the EAR APPLICATOR, CATALOG NO. 2229. Classified as Applicator, Absorbent Tipped, Non-sterile (product code KXF), Class I - General Controls.
Submitted by Treace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on March 6, 1987 after a review of 8 days - a notably fast clearance cycle.
This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6025 - 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.
| Product Code | KXF Applicator, Absorbent Tipped, Non-sterile |
| Device Class | Class 1 - General Controls |
| CFR Regulation | 21 CFR 880.6025 |
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.
Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.