Cleared Traditional

K944545 - BODY FLUIDS BARRIER KIT

K944545 is an FDA 510(k) clearance for BODY FLUIDS BARRIER KIT, manufactured by Ani Safety, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K944545 · Ani Safety, Inc. · General Hospital
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Nov 1994
Decision
47d
Days
Class 2
Risk

K944545 is an FDA 510(k) clearance for the BODY FLUIDS BARRIER KIT. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Ani Safety, Inc. (Skokie, US). The FDA issued a Cleared decision on November 2, 1994 after a review of 47 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 Ani Safety, Inc. devices

FDA 510(k) Submission Details - K944545

510(k) Number K944545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1994
Decision Date November 02, 1994
Days to Decision 47 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
82d faster than avg
Panel avg: 129d · This submission: 47d
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 516
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