Cleared Abbreviated

K024249 - TERUMO SURGUARD SAFETY SYRINGE

K024249 is an FDA 510(k) clearance for TERUMO SURGUARD SAFETY SYRINGE, manufactured by Terumo Medical Corp.. The device is a Class 2 General Hospital device with product code MEG cleared through the Abbreviated 510(k) pathway after a 60-day FDA review.

K024249 · Terumo Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
60d
Days
Class 2
Risk

K024249 is an FDA 510(k) clearance for the TERUMO SURGUARD SAFETY SYRINGE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on February 21, 2003 after a review of 60 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Terumo Medical Corp. devices

FDA 510(k) Submission Details - K024249

510(k) Number K024249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2002
Decision Date February 21, 2003
Days to Decision 60 days
Submission Type Abbreviated
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
69d faster than avg
Panel avg: 129d · This submission: 60d
Pathway characteristics
Standards-based clearance path.

MEG Device Classification - Class 2, Special Controls

Product Code MEG Syringe, Antistick
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 - MEG Syringe, Antistick

All 139
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K024249.
TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM
K042712 · Safety Syringes, Inc. · Oct 2004
TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-100 INSULIN/FA78 SERIES TUBERCULIN)
K042426 · Taiject Medical Device Co., Ltd. · Sep 2004
BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND 10CC/ML
K041970 · Biotop Technology Co., Ltd. · Aug 2004
EXEL SECURETOUCH PTP SYRINGE
K011754 · Exelint Intl. Co. · Jan 2003
TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML)
K023458 · Taiject Medical Device Co., Ltd. · Nov 2002
1CC FUTURA SAFETY SYRINGE
K023323 · Futura Medical Technology · Oct 2002