Cleared Traditional

Savvy Mask - Level 3 Surgical Face Mask (K213406) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213406 · Texas Medplast, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2021
Decision
30d
Days
Class 2
Risk

K213406 is an FDA 510(k) clearance for the Savvy Mask - Level 3 Surgical Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Texas Medplast, LLC (Houston, US). The FDA issued a Cleared decision on November 18, 2021 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Texas Medplast, LLC devices

Submission Details

510(k) Number K213406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2021
Decision Date November 18, 2021
Days to Decision 30 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 129d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code FXX Mask, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
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 General Hospital devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
Prithul Bom

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 - FXX Mask, Surgical

All 404
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K213406.
Surgical Mask (sterile)
K211295 · Nanjing 3h Medical Products Co., Ltd. · Nov 2021
039 Surgical Face Mask
K211956 · Aok Tooling Limited · Nov 2021
Impertech Surgical Face Mask
K212046 · Impertech Industries , Ltd. · Nov 2021
Disposable Surgical Mask
K210042 · Suzhou Letian Protective Products Co., Ltd. · Nov 2021
Surgical Mask
K212344 · Xiantao Dingcheng Non-Woven Product Co., Ltd. · Nov 2021
Spin Care Disposable Protective Mask Level 3
K212109 · Spintech, LLC · Nov 2021

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.