Cleared Traditional

K212928 - Lorals

K212928 is an FDA 510(k) clearance for Lorals, manufactured by Brazen Goods Inc. Dba Lorals. The device is a Class 2 Obstetrics & Gynecology device with product code MSC cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K212928 · Brazen Goods Inc. Dba Lorals · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
220d
Days
Class 2
Risk

K212928 is an FDA 510(k) clearance for the Lorals. Classified as Barrier, Std, Oral Sex (product code MSC), Class II - Special Controls.

Submitted by Brazen Goods Inc. Dba Lorals (Los Angeles, US). The FDA issued a Cleared decision on April 22, 2022 after a review of 220 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 Brazen Goods Inc. Dba Lorals devices

FDA 510(k) Submission Details - K212928

510(k) Number K212928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2021
Decision Date April 22, 2022
Days to Decision 220 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
59d slower than avg
Panel avg: 161d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Acknowledge Regulatory Strategies, LLC
Erin Gontang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MSC Barrier, Std, Oral Sex

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