Cleared Traditional

K896898 - BOWEN ELECTRODE SKIN PREPATORY CLEANSER

K896898 · Bowen & Company, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1990
Decision
117d
Days
-
Risk

K896898 is an FDA 510(k) clearance for the BOWEN ELECTRODE SKIN PREPATORY CLEANSER. Classified as Pad, Alcohol, Device Disinfectant (product code LKB).

Submitted by Bowen & Company, Inc. (Rockville, US). The FDA issued a Cleared decision on April 4, 1990 after a review of 117 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Bowen & Company, Inc. devices

FDA 510(k) Submission Details - K896898

510(k) Number K896898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1989
Decision Date April 04, 1990
Days to Decision 117 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
12d faster than avg
Panel avg: 129d · This submission: 117d
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 14
Devices cleared under the same product code (LKB) and FDA review panel - the closest regulatory comparables to K896898.
SITESCRUB IPA DEVICE
K112791 · C. R. Bard · Feb 2012
I.V. STARR KIT
K912161 · Medical Device Inspection Co., Inc. · Oct 1991
HEXIDIS ALCOHOL SWAB
K910735 · Specialites Septodont · Apr 1991
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