Cleared Traditional

K884448 - BLADEMATE

K884448 is an FDA 510(k) clearance for BLADEMATE, manufactured by V.I.R. Engineering, Inc.. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K884448 · V.I.R. Engineering, Inc. · General Hospital
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Nov 1988
Decision
27d
Days
Class 2
Risk

K884448 is an FDA 510(k) clearance for the BLADEMATE. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by V.I.R. Engineering, Inc. (Goleta, US). The FDA issued a Cleared decision on November 17, 1988 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 V.I.R. Engineering, Inc. devices

FDA 510(k) Submission Details - K884448

510(k) Number K884448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1988
Decision Date November 17, 1988
Days to Decision 27 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 129d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MMK Device Classification - Class 2, Special Controls

Product Code MMK Container, Sharps
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - MMK Container, Sharps

All 87
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K884448.
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