Cleared Traditional

K890514 - PRE-MOISTENED CLEANSING PAD

K890514 · Bausch & Lomb, Inc. · General Hospital
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Apr 1989
Decision
68d
Days
-
Risk

K890514 is an FDA 510(k) clearance for the PRE-MOISTENED CLEANSING PAD. Classified as Pad, Alcohol, Device Disinfectant (product code LKB).

Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on April 10, 1989 after a review of 68 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 Bausch & Lomb, Inc. devices

FDA 510(k) Submission Details - K890514

510(k) Number K890514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1989
Decision Date April 10, 1989
Days to Decision 68 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
61d faster than avg
Panel avg: 129d · This submission: 68d
Pathway characteristics
Predicate-based equivalence.

LKB Device Classification - Class 0,

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

Regulatory Peers - LKB Pad, Alcohol, Device Disinfectant

All 12
Devices cleared under the same product code (LKB) and FDA review panel - the closest regulatory comparables to K890514.
BAXTER ACETONE-ALCOHOL PREP PADS, STERILE
K893958 · Span-America Medical Systems, Inc. · Oct 1989
BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE
K894791 · Span-America Medical Systems, Inc. · Oct 1989
DRI-VENT ARTERIAL BLOOD SAMPLING KIT
K883840 · Concord Laboratories, Inc. · May 1989
AMERICAN ALCOHOL PREP PAD STERILE MEDIUM
K870718 · Span-America Medical Systems, Inc. · May 1987
ACETONE ALCOHOL SWABS
K833936 · Concord Laboratories, Inc. · Jan 1984
ALCOHOL SWABS
K833993 · Concord Laboratories, Inc. · Jan 1984