Cleared Traditional

K121655 - BD ALCOHOL SWAB

K121655 · Becton, Dickinson & CO · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
288d
Days
-
Risk

K121655 is an FDA 510(k) clearance for the BD ALCOHOL SWAB. Classified as Pad, Alcohol, Device Disinfectant (product code LKB).

Submitted by Becton, Dickinson & CO (Franklin Lakes, US). The FDA issued a Cleared decision on March 20, 2013 after a review of 288 days - an extended review 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: 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.

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FDA 510(k) Submission Details - K121655

510(k) Number K121655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2012
Decision Date March 20, 2013
Days to Decision 288 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
159d slower than avg
Panel avg: 129d · This submission: 288d
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 7
Devices cleared under the same product code (LKB) and FDA review panel - the closest regulatory comparables to K121655.
I.V. STARR KIT
K912161 · Medical Device Inspection Co., Inc. · Oct 1991
DRI-VENT ARTERIAL BLOOD SAMPLING KIT
K883840 · Concord Laboratories, Inc. · May 1989
PRE-MOISTENED CLEANSING PAD
K890514 · Bausch & Lomb, Inc. · Apr 1989
ACETONE ALCOHOL SWABS
K833936 · Concord Laboratories, Inc. · Jan 1984
ALCOHOL SWABS
K833993 · Concord Laboratories, Inc. · Jan 1984
ONE TIME ACETONE/ALCOHOL
K833141 · Acme United Corp. · Oct 1983