Cleared Traditional

K053413 - TERUMO SYRINGE FOR ADMINISTRATION OF UV...

K053413 is the FDA 510(k) clearance for TERUMO SYRINGE FOR ADMINISTRATION OF UV... by Terumo Europe N.V.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K053413 · Terumo Europe N.V. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
120d
Days
Class 2
Risk

K053413 is an FDA 510(k) clearance for the TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Terumo Europe N.V. (Leuven, BE). The FDA issued a Cleared decision on April 6, 2006 after a review of 120 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 Terumo Europe N.V. devices

Submission Details

510(k) Number K053413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2005
Decision Date April 06, 2006
Days to Decision 120 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
9d faster than avg
Panel avg: 129d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 313
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K053413.
MODIFICATION TO BONE GRAFT SYRINGE
K062173 · Wrightmedicaltechnologyinc · Aug 2006
MEDLINE SYRINGES, MULTIPLE
K061275 · Medline Industries, Inc. · Jul 2006
AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE
K061039 · Amsino International, Inc. · Jun 2006
MODIFICATION TO: VACLOK SYRINGE
K060095 · Wrightmedicaltechnologyinc · Feb 2006
B. BRAUN 0.2 MICRON FILTER
K052773 · B.Braun Medical, Inc. · Jan 2006
NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE
K051574 · Nipro Medical Corp. · Aug 2005