Cleared Traditional

CPL Surgical Face Mask (K213136) - FDA 510(k) Clearance

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

K213136 · Control Print Limited · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2021
Decision
88d
Days
Class 2
Risk

K213136 is an FDA 510(k) clearance for the CPL Surgical Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Control Print Limited (District Solan, IN). The FDA issued a Cleared decision on December 24, 2021 after a review of 88 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 Control Print Limited devices

Submission Details

510(k) Number K213136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2021
Decision Date December 24, 2021
Days to Decision 88 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 129d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

Liberty Management Group , Ltd.
Manoj Zacharias

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 K213136.
Medical Surgical Mask
K212299 · Wepon Medical Technology Co., Ltd. · Jan 2022
Disposable Medical Surgical Mask
K212375 · Jiangxi Bestgrand Health Technology Co., Ltd. · Jan 2022
Skypro, SP02 Mask (3)
K202255 · Skypro Medical Supplies Company · Dec 2021
Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield
K210147 · Unicoglobal, Inc. · Dec 2021
Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)
K211750 · National Bridge Industrial (S.Z.) Co., Ltd. · Dec 2021
Topwide Surgical Face Mask
K210102 · Topwide (Hubei) Medical Products Manufacturer · Dec 2021