Cleared Traditional

K950554 - NORTH BLOODBORNE PATHOGEN RESPONSE KIT

K950554 is an FDA 510(k) clearance for NORTH BLOODBORNE PATHOGEN RESPONSE KIT, manufactured by North Safety Products. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K950554 · North Safety Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
145d
Days
Class 2
Risk

K950554 is an FDA 510(k) clearance for the NORTH BLOODBORNE PATHOGEN RESPONSE KIT. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by North Safety Products (Rockford, US). The FDA issued a Cleared decision on June 28, 1995 after a review of 145 days - within the typical 510(k) review window.

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.

View all North Safety Products devices

FDA 510(k) Submission Details - K950554

510(k) Number K950554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1995
Decision Date June 28, 1995
Days to Decision 145 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 129d · This submission: 145d
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 509
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K950554.
GLOBAL HEALTHCARE FACE MASK
K953754 · Global Healthcare, Inc. · Jan 1996
BODY FLUID BARRIER KIT
K952961 · Lhb Industries, Inc. · Jan 1996
BLOODBORNE PATHOGEN KIT
K953102 · Certified Safety Mfg., Inc. · Dec 1995
PENTAX FACE MASK
K933683 · Pentax Precision Instrument Corp. · Jun 1995
BUSSE ISOLATION AND PROCEDURAL MASKS
K940720 · Busse Hospital Disposables, Inc. · Nov 1994
3M SURGICAL MASK WITH FACE SHEILD
K940707 · 3M Company · May 1994