Cleared Traditional

K970547 - ISOLYSER SDS SHARPS CONTAINER

K970547 is an FDA 510(k) clearance for ISOLYSER SDS SHARPS CONTAINER, manufactured by Thantex Specialties, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K970547 · Thantex Specialties, Inc. · General Hospital
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Jul 1997
Decision
156d
Days
Class 2
Risk

K970547 is an FDA 510(k) clearance for the ISOLYSER SDS SHARPS CONTAINER. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Thantex Specialties, Inc. (Norcross, US). The FDA issued a Cleared decision on July 18, 1997 after a review of 156 days - an extended review 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: 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 Thantex Specialties, Inc. devices

FDA 510(k) Submission Details - K970547

510(k) Number K970547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1997
Decision Date July 18, 1997
Days to Decision 156 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 129d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

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 540
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K970547.
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K963748 · Bio-Plexus, Inc. · Jun 1997