Cleared Special

SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16 (K021197) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K021197 · Hosuk Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
10d
Days
Class 2
Risk

K021197 is an FDA 510(k) clearance for the SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Hosuk Co., Ltd. (Minneapolis, US). The FDA issued a Cleared decision on April 26, 2002 after a review of 10 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hosuk Co., Ltd. devices

Submission Details

510(k) Number K021197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2002
Decision Date April 26, 2002
Days to Decision 10 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 129d · This submission: 10d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 209
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K021197.
PCCS GRAFT DELIVERY SYSTEM
K021071 · Biomet, Inc. · Jul 2002
DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML
K020666 · Baxter Healthcare Corp · Jun 2002
DUPLOREACH
K014088 · Baxter Healthcare Corp · Jun 2002
STERILE PISTON SYRINGE
K002717 · Abbott Laboratories · Jan 2001
DUPLOGRIP
K003193 · Baxter Healthcare Corp · Nov 2000
TISSOMAT AND SPRAY SET
K981089 · Baxter Healthcare Corp · Jul 2000