Cleared Special

K020544 - WING SAFE INFUSION SET 20 GA, SHS2000 SERIES

Also marketed or referenced as:
WING SAFE INFUSION SET 19 GA, SHS1900 SERIES WING SAFE INFUSION SET 22 GA

K020544 is an FDA 510(k) clearance for WING SAFE INFUSION SET 20 GA, manufactured by Churchill Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Special 510(k) pathway after a 25-day FDA review.

K020544 · Churchill Medical Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
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Mar 2002
Decision
25d
Days
Class 2
Risk

K020544 is an FDA 510(k) clearance for the WING SAFE INFUSION SET 20 GA, SHS2000 SERIES. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Churchill Medical Systems, Inc. (Dover, US). The FDA issued a Cleared decision on March 12, 2002 after a review of 25 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K020544

510(k) Number K020544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2002
Decision Date March 12, 2002
Days to Decision 25 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 129d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 1099
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K020544.
LIFEGUARD SAFETY INFUSION SET
K013871 · Horizon Medical Products, Inc. · Mar 2002
CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP
K013714 · Codan US Corp. · Mar 2002
UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR
K013949 · Churchill Medical Systems, Inc. · Mar 2002
EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE
K012879 · Exelint Intl. Co. · Jan 2002
SIMPLICITY STARPLUS SOFT INFUSION SET
K014061 · Sterling Medivations, Inc. · Jan 2002
SIMPLICITY EASY ACCESS INFUSION SET
K014062 · Sterling Medivations, Inc. · Jan 2002
K020544 · WING SAFE INFUSION SET 20 GA, SHS2000 SERIES
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