Cleared Traditional

K850325 - STERILE SUTURE REMOVAL KIT

K850325 is the FDA 510(k) clearance for STERILE SUTURE REMOVAL KIT by Excel Health Care Products. It is a Class 1 General & Plastic Surgery device (product code KDD) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K850325 · Excel Health Care Products · General & Plastic Surgery device
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Feb 1985
Decision
29d
Days
Class 1
Risk

K850325 is an FDA 510(k) clearance for the STERILE SUTURE REMOVAL KIT. Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by Excel Health Care Products (S. Plainfield, US). The FDA issued a Cleared decision on February 26, 1985 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 Excel Health Care Products devices

Submission Details

510(k) Number K850325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1985
Decision Date February 26, 1985
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KDD Kit, Surgical Instrument, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

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.

Regulatory Peers - KDD Kit, Surgical Instrument, Disposable

Devices cleared under the same product code (KDD) and FDA review panel - the closest regulatory comparables to K850325.
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