Cleared Traditional

K053413 - TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES

K053413 is an FDA 510(k) clearance for TERUMO SYRINGE FOR ADMINISTRATION OF UV..., manufactured by Terumo Europe N.V.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K053413

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.

FMF Device Classification - Class 2, Special Controls

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 529
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K053413.
AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE
K061039 · Amsino International, Inc. · Jun 2006
CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005-093
K061183 · Confluent Surgical,Inc · Jun 2006
HUMAPEN MEMOIR
K053563 · Eli Lilly and Company · Apr 2006
MODIFICATION TO: VACLOK SYRINGE
K060095 · Wrightmedicaltechnologyinc · Feb 2006
WUZHOU SYRINGE, WITH/WITHOUT NEEDLE
K060211 · Wenzhou Wuzhou Group Co. , Ltd. · Feb 2006
B. BRAUN 0.2 MICRON FILTER
K052773 · B.Braun Medical, Inc. · Jan 2006