Cleared Traditional

K212273 - Cross Protection ResQ300 Plus Surgical ...

K212273 is an FDA 510(k) clearance for Cross Protection ResQ300 Plus Surgical ..., manufactured by Cross Protection (M) Sdn Bhd. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 393-day FDA review.

K212273 · Cross Protection (M) Sdn Bhd · General Hospital
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Aug 2022
Decision
393d
Days
Class 2
Risk

K212273 is an FDA 510(k) clearance for the Cross Protection ResQ300 Plus Surgical Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Cross Protection (M) Sdn Bhd (Klang, MY). The FDA issued a Cleared decision on August 17, 2022 after a review of 393 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Cross Protection (M) Sdn Bhd devices

FDA 510(k) Submission Details - K212273

510(k) Number K212273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2021
Decision Date August 17, 2022
Days to Decision 393 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
264d slower than avg
Panel avg: 129d · This submission: 393d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FXX Device Classification - Class 2, Special Controls

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 Peers - FXX Mask, Surgical

All 444
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K212273.
Medical Surgery Mask, Model:2626-7
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