Cleared Traditional

K896835 - ALCOHOL PREP AND POVIDONE-IODINE PREP

K896835 · Norpak Mfg., Inc. · General Hospital

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Jan 1990

Decision

37d

Days

Risk

K896835 is an FDA 510(k) clearance for the ALCOHOL PREP AND POVIDONE-IODINE PREP. Classified as Pad, Alcohol, Device Disinfectant (product code LKB).

Submitted by Norpak Mfg., Inc. (Ajax, Ontario L1z 1e2, CA). The FDA issued a Cleared decision on January 11, 1990 after a review of 37 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 Norpak Mfg., Inc. devices

FDA 510(k) Submission Details - K896835

510(k) Number	K896835 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 05, 1989
Decision Date	January 11, 1990
Days to Decision	37 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

92d faster than avg

Panel avg: 129d · This submission: 37d

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 K896835.

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

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 K896835

Norpak Mfg., Inc.

Ajax, Ontario L1z 1e2 · CA

MICHAEL CRUICKSHANK

Regulatory profile

2 submissions 2 cleared

100% 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 11, 1990. Record added to 510k Database: March 2026.

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