Cleared Traditional

ALCOHOL PREP AND POVIDONE-IODINE PREP (K896835) - FDA 510(k) Clearance

K896835 · Norpak Mfg., Inc. · General Hospital
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Jan 1990
Decision
37d
Days
-
Risk

K896835 is an FDA 510(k) clearance for the ALCOHOL PREP AND POVIDONE-IODINE PREP. Classified as Pad, Alcohol, Device Disinfectant (product code LKB).

Submitted by Norpak Mfg., Inc. (Ajax, Ontario L1z 1e2, CA). The FDA issued a Cleared decision on January 11, 1990 after a review of 37 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 Norpak Mfg., Inc. devices

Submission Details

510(k) Number K896835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1989
Decision Date January 11, 1990
Days to Decision 37 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
92d faster than avg
Panel avg: 129d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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