Cleared Traditional

K212037 - SancDam Latex Oral Dam (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K212037 · Sanctuary Health Sdn. Bhd. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Mar 2022
Decision
271d
Days
Class 2
Risk

K212037 is an FDA 510(k) clearance for the SancDam Latex Oral Dam. Classified as Barrier, Std, Oral Sex (product code MSC), Class II - Special Controls.

Submitted by Sanctuary Health Sdn. Bhd. (Chemor, MY). The FDA issued a Cleared decision on March 28, 2022 after a review of 271 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 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 Sanctuary Health Sdn. Bhd. devices

Submission Details

510(k) Number K212037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2021
Decision Date March 28, 2022
Days to Decision 271 days
Submission Type Traditional
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
111d slower than avg
Panel avg: 160d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.