510(k) · Cleared

Cleared

SancDam Latex Oral Dam

K212037510(k) TraditionalCleared Mar 28, 2022271-day reviewClass II21 CFR 884.5300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sanctuary Health Sdn. Bhd. · MSC Barrier, Std, Oral Sex

Cleared on Mar 28, 2022 as substantially equivalent to K091769 (Line One Laboratories, Inc., 2010) after a 271-day review. Its family tree reaches back 2 generations to 1999.

Decided: Mar 28, 2022
Review: 271 days
Class: Class II
Product code: MSC
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K990067 (1999). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK990067 Sheer Glyde DamsLouise C. Myers · 1999
1 generation backK091769 Trust DamLine One Laboratories, Inc. · 2010
This deviceK212037 SancDam Latex Oral DamSanctuary Health Sdn. Bhd. · 2022

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K990067	Sheer Glyde Dams	Louise C. Myers	1999	—
−1	K091769	Trust Dam	Line One Laboratories, Inc.	2010	—
0 (this device)	K212037	SancDam Latex Oral Dam	Sanctuary Health Sdn. Bhd.	2022	—

FIG. 1 — Lineage of K212037, 1999–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MSC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MSC device

#1 K253662 Lixi (LXOSFM1)score 12.3 · 3 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K091769	Trust Dam Summary page 4 …Line One Laboratories, Inc. Predicate Device Common Latex Dam Name Predicate Device Proprietary Line One Trust Dam Name Predicate Device Premarket K091769 Notification # Predicate Device Classification 21 CFR 884.5300 - Condom Predicate Device Class II Predicate Device…	Line One Laboratories, Inc.	2010	—

Also cleared against K091769: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 12.1 years on median.
None of the 2 ancestors has a recall.
2 other devices also cite its predicate K091769.

How does its category compare?

All MSC devices

MSC Barrier, Std, Oral Sex: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · MSC

2in 2022

2007high 2 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MSC

Too few MSC 510(k)s in any year since 2007 to give a median.

Recalls per year · MSC

No recall names MSC since 2007.

Adverse event reports per year · MSC

No MAUDE report names MSC since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	1	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	1	—	0
2022	2	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	1	—	—

What is it indicated for?

The SancDamTM Latex Oral Dam is used as a barrier when engaging in oral/vaginal and oral/anal sex to help reduce the transmission of bodily fluids, harmful pathogens, and sexually transmitted infections.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K212037 · printed Nov 5, 2026

Cite this page

510(k) Report. “K212037: SancDam Latex Oral Dam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212037

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026