Cleared Traditional

ALBA HEALTH CARE IODOFORM PACKING STRIP (K864689) - FDA 510(k) Clearance

K864689 · Alba Health Care · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1987
Decision
49d
Days
-
Risk

K864689 is an FDA 510(k) clearance for the ALBA HEALTH CARE IODOFORM PACKING STRIP.

Submitted by Alba Health Care (Valdese, US). The FDA issued a Cleared decision on January 20, 1987 after a review of 49 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 Alba Health Care devices

Submission Details

510(k) Number K864689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1986
Decision Date January 20, 1987
Days to Decision 49 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
66d faster than avg
Panel avg: 115d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -