Cleared Traditional

K953102 - BLOODBORNE PATHOGEN KIT

K953102 is an FDA 510(k) clearance for BLOODBORNE PATHOGEN KIT, manufactured by Certified Safety Mfg., Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K953102 · Certified Safety Mfg., Inc. · General Hospital
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Dec 1995
Decision
161d
Days
Class 2
Risk

K953102 is an FDA 510(k) clearance for the BLOODBORNE PATHOGEN KIT. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Certified Safety Mfg., Inc. (Kansas City, US). The FDA issued a Cleared decision on December 11, 1995 after a review of 161 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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.

FDA 510(k) Submission Details - K953102

510(k) Number K953102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1995
Decision Date December 11, 1995
Days to Decision 161 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 129d · This submission: 161d
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 561
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K953102.
SURGICAL MASK (NON-STERILE)
K955513 · United Medical Ent., Inc. · Apr 1996
GLOBAL HEALTHCARE FACE MASK
K953754 · Global Healthcare, Inc. · Jan 1996
BODY FLUID BARRIER KIT
K952961 · Lhb Industries, Inc. · Jan 1996
OVAL SURGICAL FACE MASK
K951913 · Oval Industries, Ltd. · Oct 1995
EZ-PERSONAL PROTECTION KIT
K952962 · Safetec of America, Inc. · Sep 1995
NORTH BLOODBORNE PATHOGEN RESPONSE KIT
K950554 · North Safety Products · Jun 1995
K953102 · BLOODBORNE PATHOGEN KIT
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