Cleared Traditional

K901416 - CONDOM (RUBBER) CONTRACEPTIVE

K901416 is an FDA 510(k) clearance for CONDOM (RUBBER) CONTRACEPTIVE, manufactured by Aladan Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K901416 · Aladan Corp. · Obstetrics & Gynecology device
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Jun 1990
Decision
70d
Days
Class 2
Risk

K901416 is an FDA 510(k) clearance for the CONDOM (RUBBER) CONTRACEPTIVE. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Aladan Corp. (Dothan, US). The FDA issued a Cleared decision on June 4, 1990 after a review of 70 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 - K901416

510(k) Number K901416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1990
Decision Date June 04, 1990
Days to Decision 70 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
91d faster than avg
Panel avg: 161d · This submission: 70d
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 294
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K901416.
MINT SCENTED CONDOMS
K900679 · Schmid Laboratories, Inc. · Jun 1990
RUBBER CONTRACEPTIVE (CONDOM)
K896142 · Guangzhou No. 11 Rubber Factory · Jun 1990
RUBBER CONDOM (NON-COLORED)
K896987 · Hankook Latex Gongup Co., Ltd. · Jun 1990
CONDOMS (MULTIPLE BRANDS)
K897129 · Sagami, Inc. · May 1990
CONDOM (RUBBER) CONTRACEPTIVE
K893039 · Chinteik Hygiene Products Co., Ltd. · May 1990
TROJANS LATEX CONDOMS (MODIFIED LABELING)
K901190 · Carter Products · Apr 1990
K901416 · CONDOM (RUBBER) CONTRACEPTIVE
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