Cleared Traditional

K860961 - GAMMA RADIATION STERILIZED ALCOHOL PREP PADS

K860961 · H & P Industries, Inc. · General Hospital
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Apr 1986
Decision
27d
Days
-
Risk

K860961 is an FDA 510(k) clearance for the GAMMA RADIATION STERILIZED ALCOHOL PREP PADS. Classified as Pad, Alcohol, Device Disinfectant (product code LKB).

Submitted by H & P Industries, Inc. (Franklin, US). The FDA issued a Cleared decision on April 9, 1986 after a review of 27 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 H & P Industries, Inc. devices

FDA 510(k) Submission Details - K860961

510(k) Number K860961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1986
Decision Date April 09, 1986
Days to Decision 27 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
102d faster than avg
Panel avg: 129d · This submission: 27d
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 K860961.
DRI-VENT ARTERIAL BLOOD SAMPLING KIT
K883840 · Concord Laboratories, Inc. · May 1989
PRE-MOISTENED CLEANSING PAD
K890514 · Bausch & Lomb, Inc. · Apr 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
ONE TIME ACETONE/ALCOHOL
K833141 · Acme United Corp. · Oct 1983