Cleared Traditional

K851390 - STERILE GENERAL HOSPITAL SUPPLIES (FDA 510(k) Clearance)

K851390 · Biological & Environmental Control Laboratories · General & Plastic Surgery device
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May 1985
Decision
50d
Days
-
Risk

K851390 is an FDA 510(k) clearance for the STERILE GENERAL HOSPITAL SUPPLIES.

Submitted by Biological & Environmental Control Laboratories (Toledo, US). The FDA issued a Cleared decision on May 29, 1985 after a review of 50 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.

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Submission Details

510(k) Number K851390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1985
Decision Date May 29, 1985
Days to Decision 50 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
64d faster than avg
Panel avg: 114d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDQ
Device Class -