Cleared Abbreviated

K091769 - TRUST DAM

K091769 is an FDA 510(k) clearance for TRUST DAM, manufactured by Line One Laboratories, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MSC cleared through the Abbreviated 510(k) pathway after a 234-day FDA review.

K091769 · Line One Laboratories, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
234d
Days
Class 2
Risk

K091769 is an FDA 510(k) clearance for the TRUST DAM. Classified as Barrier, Std, Oral Sex (product code MSC), Class II - Special Controls.

Submitted by Line One Laboratories, Inc. (Durham, US). The FDA issued a Cleared decision on February 5, 2010 after a review of 234 days - an extended review 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K091769

510(k) Number K091769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2009
Decision Date February 05, 2010
Days to Decision 234 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 161d · This submission: 234d
Pathway characteristics
Standards-based clearance path.

MSC Device Classification - Class 2, Special Controls

Product Code MSC Barrier, Std, Oral Sex
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 - MSC Barrier, Std, Oral Sex

Devices cleared under the same product code (MSC) and FDA review panel - the closest regulatory comparables to K091769.
Lorals
K212928 · Brazen Goods Inc. Dba Lorals · Apr 2022
SancDam Latex Oral Dam
K212037 · Sanctuary Health Sdn. Bhd. · Mar 2022
Harmony Latex Dam, Harmony Non-Latex Dam
K203727 · Pamco Distributing, Inc. · Aug 2021
SHEER GLYDE DAMS
K990067 · Louise C. Myers · Feb 1999
GLYDE DAM LOLLYES
K970577 · Glyde USA, Inc. · Jan 1998
K091769 · TRUST DAM
Download PDF FDA Summary Line One Laboratories…