Cleared Traditional

K897129 - CONDOMS (MULTIPLE BRANDS)

K897129 is an FDA 510(k) clearance for CONDOMS (MULTIPLE BRANDS), manufactured by Sagami, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K897129 · Sagami, Inc. · Obstetrics & Gynecology device
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May 1990
Decision
141d
Days
Class 2
Risk

K897129 is an FDA 510(k) clearance for the CONDOMS (MULTIPLE BRANDS). Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Sagami, Inc. (Chicago, US). The FDA issued a Cleared decision on May 16, 1990 after a review of 141 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sagami, Inc. devices

FDA 510(k) Submission Details - K897129

510(k) Number K897129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1989
Decision Date May 16, 1990
Days to Decision 141 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 160d · This submission: 141d
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 202
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K897129.
CONDOM (RUBBER) CONTRACEPTIVE
K905279 · Aladan Corp. · Feb 1991
TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED
K901202 · Carter Products · Jun 1990
CONDOM (RUBBER) CONTRACEPTIVE
K901416 · Aladan Corp. · Jun 1990
TROJANS LATEX CONDOMS (MODIFIED LABELING)
K901190 · Carter Products · Apr 1990
TROJAN-ENZ LATEX CONDOMS (MODIFIED LABELING)
K901191 · Carter Products · Apr 1990
TROJAN-ENZ LUBRI. CONDOMS (MODIFIED LABELING)
K901192 · Carter Products · Apr 1990