Cleared Traditional

K070264 - 50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB

K070264 is an FDA 510(k) clearance for 50 ML TERUMO SYRINGE FOR ADMINISTRATION..., 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.

K070264 · Terumo Europe N.V. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
120d
Days
Class 2
Risk

K070264 is an FDA 510(k) clearance for the 50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB. 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 May 29, 2007 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.

FDA 510(k) Submission Details - K070264

510(k) Number K070264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2007
Decision Date May 29, 2007
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 755
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K070264.
FEEL-JECT INSULIN SYRINGE
K070917 · Feel Tech · Jun 2007
GENIE, MODEL CH-200
K070633 · Icu Medical, Inc. · Jun 2007
MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP
K070814 · Confluent Surgical,Inc · May 2007
EVICEL APPLICATION DEVICE
K070575 · Omrix Biopharmaceuticals , Ltd. · May 2007
TEXIUM SYRINGE
K071108 · Cardinal Health, Alaris Products · May 2007
HASELMEIER PEN
K070100 · Haselmeier Sarl · Mar 2007
K070264 · 50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB
Download PDF FDA Summary Terumo Europe N.V.