Cleared Traditional

K852235 - STERETS INJECTION SWAB (FDA 510(k) Clearance)

K852235 · Ellis Pharmaceutical Consulting, Inc. · General Hospital
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Jun 1985
Decision
16d
Days
-
Risk

K852235 is an FDA 510(k) clearance for the STERETS INJECTION SWAB. Classified as Pad, Alcohol, Device Disinfectant (product code LKB).

Submitted by Ellis Pharmaceutical Consulting, Inc. (Princeton, US). The FDA issued a Cleared decision on June 7, 1985 after a review of 16 days - a notably fast clearance cycle.

This device falls under the General Hospital 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 Ellis Pharmaceutical Consulting, Inc. devices

Submission Details

510(k) Number K852235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1985
Decision Date June 07, 1985
Days to Decision 16 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 128d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKB Pad, Alcohol, Device Disinfectant
Device Class -