Cleared Traditional

BIG PHIL (K946027) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K946027 · Biomedical Waste Systems, Inc. · General Hospital
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Jan 1995
Decision
48d
Days
Class 2
Risk

K946027 is an FDA 510(k) clearance for the BIG PHIL. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Biomedical Waste Systems, Inc. (Boston, US). The FDA issued a Cleared decision on January 26, 1995 after a review of 48 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 Biomedical Waste Systems, Inc. devices

Submission Details

510(k) Number K946027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1994
Decision Date January 26, 1995
Days to Decision 48 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
81d faster than avg
Panel avg: 129d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMI Needle, Hypodermic, Single Lumen
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 - FMI Needle, Hypodermic, Single Lumen

All 191
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K946027.
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MONOJECT(R) VERTICAL ENTRY SHARPS CONTAINER (1 QT)
K945809 · Sherwood Medical Co. · Mar 1995
PISTON SYRINGES
K944757 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1995
CHEMOTHERAPY SHARPS DISPOSAL CONTAINERS
K943722 · Baxter Healthcare Corp · Nov 1994
B-D GUARDIAN NESTABLE SHARPS COLLECTORS
K943575 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1994