Cleared Traditional

K862219 - T.P.N. DRESSING CHANGE TRAY (FDA 510(k) Clearance)

K862219 · Welmed Systems, Inc. · General & Plastic Surgery device
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Jul 1986
Decision
27d
Days
-
Risk

K862219 is an FDA 510(k) clearance for the T.P.N. DRESSING CHANGE TRAY.

Submitted by Welmed Systems, Inc. (West Swanzey, US). The FDA issued a Cleared decision on July 8, 1986 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery 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 Welmed Systems, Inc. devices

Submission Details

510(k) Number K862219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received June 11, 1986
Decision Date July 08, 1986
Days to Decision 27 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
87d faster than avg
Panel avg: 114d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -