Cleared Traditional

K870718 - AMERICAN ALCOHOL PREP PAD STERILE MEDIUM

K870718 · Span-America Medical Systems, Inc. · General Hospital
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May 1987
Decision
76d
Days
-
Risk

K870718 is an FDA 510(k) clearance for the AMERICAN ALCOHOL PREP PAD STERILE MEDIUM. Classified as Pad, Alcohol, Device Disinfectant (product code LKB).

Submitted by Span-America Medical Systems, Inc. (Greenville, US). The FDA issued a Cleared decision on May 7, 1987 after a review of 76 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 Span-America Medical Systems, Inc. devices

FDA 510(k) Submission Details - K870718

510(k) Number K870718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1987
Decision Date May 07, 1987
Days to Decision 76 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 129d · This submission: 76d
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 13
Devices cleared under the same product code (LKB) and FDA review panel - the closest regulatory comparables to K870718.
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
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