Cleared Traditional

K970398 - SHARPS CONTAINER

K970398 is an FDA 510(k) clearance for SHARPS CONTAINER, manufactured by Custom Medical Plastics, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K970398 · Custom Medical Plastics, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
150d
Days
Class 2
Risk

K970398 is an FDA 510(k) clearance for the SHARPS CONTAINER. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Custom Medical Plastics, Inc. (Omaha, US). The FDA issued a Cleared decision on July 3, 1997 after a review of 150 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 Custom Medical Plastics, Inc. devices

FDA 510(k) Submission Details - K970398

510(k) Number K970398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1997
Decision Date July 03, 1997
Days to Decision 150 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
21d slower than avg
Panel avg: 129d · This submission: 150d
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 444
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K970398.
SYRINGE NEEDLE REMOVER (S.N.R.)
K972536 · Post Medical, Inc. · Aug 1997
ISOLYSER SDS SHARPS CONTAINER
K970547 · Thantex Specialties, Inc. · Jul 1997
SHARPS CONTAINER
K970383 · Custom Medical Plastics, Inc. · Jul 1997
BIO-PLEXUS DROP-IT NEEDLE HOLDER
K963748 · Bio-Plexus, Inc. · Jun 1997
EXTRESAFE PHLEBOTOMY
K964042 · Specialized Health Products, Inc. · Jun 1997
VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR
K963571 · Vygon Corp. · Jun 1997