Cleared Abbreviated

K061115 - SPEEDFLOW 0.2UM FILTER, MODEL 11214

Also marketed or referenced as:
SPEEDFLOW 1.2UM FILTER, MODEL 11215 EASYDROP CONTROLLER, MODEL 11216

K061115 is an FDA 510(k) clearance for SPEEDFLOW 0.2UM FILTER, manufactured by Gvs Spa. The device is a Class 2 General Hospital device with product code FPA cleared through the Abbreviated 510(k) pathway after a 70-day FDA review.

K061115 · Gvs Spa · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
70d
Days
Class 2
Risk

K061115 is an FDA 510(k) clearance for the SPEEDFLOW 0.2UM FILTER, MODEL 11214. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Gvs Spa (Manchester, US). The FDA issued a Cleared decision on June 30, 2006 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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.

FDA 510(k) Submission Details - K061115

510(k) Number K061115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2006
Decision Date June 30, 2006
Days to Decision 70 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
59d faster than avg
Panel avg: 129d · This submission: 70d
Pathway characteristics
Standards-based clearance path.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 1143
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K061115.
INTUITION INFUSION SETS
K061374 · Unomedical A/S · Jul 2006
SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS
K061285 · Cardinal Health, Alaris Products · Jul 2006
EZ-CONNECT
K061771 · Vidacare Corporation · Jul 2006
DERMATECH IV HOLDER
K060488 · Dermatech Medical, Inc. · Jun 2006
K-SHIELD PORT ACCESS INFUSION SET
K060580 · Kawasumi Laboratories, Inc. · Jun 2006
HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS
K060352 · Health Line International Corporation · May 2006
K061115 · SPEEDFLOW 0.2UM FILTER, MODEL 11214
Download PDF FDA Summary Gvs Spa