Cleared Traditional

K133070 - SURGICAL FACE MASK (Ear Loops and Tie-on)

K133070 is an FDA 510(k) clearance for SURGICAL FACE MASK (Ear Loops and Tie-on), manufactured by Bh Medical Products Co., Ltd.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 630-day FDA review.

K133070 · Bh Medical Products Co., Ltd. · General Hospital
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Jun 2015
Decision
630d
Days
Class 2
Risk

K133070 is an FDA 510(k) clearance for the SURGICAL FACE MASK (Ear Loops and Tie-on). Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Bh Medical Products Co., Ltd. (Dover, US). The FDA issued a Cleared decision on June 22, 2015 after a review of 630 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Bh Medical Products Co., Ltd. devices

FDA 510(k) Submission Details - K133070

510(k) Number K133070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2013
Decision Date June 22, 2015
Days to Decision 630 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
501d slower than avg
Panel avg: 129d · This submission: 630d
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 Consultant

Medevice China, Ltd.
DI WU

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 505
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K133070.
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