Cleared Traditional

K833936 - ACETONE ALCOHOL SWABS

K833936 · Concord Laboratories, Inc. · General Hospital

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Jan 1984

Decision

76d

Days

Risk

K833936 is an FDA 510(k) clearance for the ACETONE ALCOHOL SWABS. Classified as Pad, Alcohol, Device Disinfectant (product code LKB).

Submitted by Concord Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 30, 1984 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 Concord Laboratories, Inc. devices

FDA 510(k) Submission Details - K833936

510(k) Number	K833936 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 15, 1983
Decision Date	January 30, 1984
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 11

Devices cleared under the same product code (LKB) and FDA review panel - the closest regulatory comparables to K833936.

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

ALCOHOL SWABS

K833993 · Concord Laboratories, Inc. · Jan 1984

ONE TIME ACETONE/ALCOHOL

K833141 · Acme United Corp. · Oct 1983

TOBRAMYCIN REAGENT TEST KIT

K813391 · Beckman Instruments, Inc. · Dec 1981

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K833936

Concord Laboratories, Inc.

Mchenry, IL · US

Regulatory profile

42 submissions 38 cleared

90% clearance rate · Active in General Hospital

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: January 30, 1984. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: August 2026.

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510k Database

510(k) clearances indexed 175,972

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