Cleared Traditional

K800518 - UTAGE-MATSU-MICRO-THIN UTAGE-SAKURA,

K800518 is an FDA 510(k) clearance for UTAGE-MATSU-MICRO-THIN UTAGE-SAKURA, manufactured by Kopharm, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K800518 · Kopharm, Inc. · Obstetrics & Gynecology device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Mar 1980

Decision

15d

Days

Class 2

Risk

K800518 is an FDA 510(k) clearance for the UTAGE-MATSU-MICRO-THIN UTAGE-SAKURA,. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Kopharm, Inc. (Walker, US). The FDA issued a Cleared decision on March 20, 1980 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology device framework. 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.

FDA 510(k) Submission Details - K800518

510(k) Number	K800518 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 05, 1980
Decision Date	March 20, 1980
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

146d faster than avg

Panel avg: 161d · This submission: 15d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

HIS Device Classification - Class 2, Special Controls

Product Code	HIS Condom
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 884.5300

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIS Condom

All 400

Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K800518.

NUDA-PLUS CONDOM W/SPERMICIDAL LUBRICANT

K822792 · Ansell, Inc. · Sep 1982

WORLD'S BEST (CONTRACEPTIVE)

K820564 · Rosen Kilde Stenhoj · May 1982

CONDOM-MULTIPAL STYLES

K813172 · Circle Rubber Corp. · Mar 1982

NATURDOM

K790433 · Juan C. Lucena · Oct 1979

PROPHYLACTIC

K772181 · Om Industries, Inc. · Dec 1977

PROPHALACTICS

K770412 · Jamar Health Products · Jun 1977

FDA 510(k) Resources - Obstetrics & Gynecology

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

Manufacturer of K800518

Kopharm, Inc.

Walker, MI · US

Regulatory profile

1 submissions 1 cleared

100% clearance rate · Active in Obstetrics & Gynecology

View all devices by Kopharm, Inc. →

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: March 20, 1980. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: November 2026.

Verify on FDA.gov

510k Database

510(k) clearances indexed 176,583

Regulatory data since 1976

FDA monthly sync November 6, 2026