Cleared Special

WING SAFE INFUSION SET 20 GA, SHS2000 SERIES (K020544) - FDA 510(k) Clearance

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

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K020544 · Churchill Medical Systems, Inc. · General Hospital
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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.

View all Churchill Medical Systems, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 129d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 208
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K020544.
LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE
K033576 · Abbott Laboratories · Dec 2003
BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER
K033350 · Becton, Dickinson & CO · Nov 2003
LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE
K030002 · Abbott Laboratories · Jan 2003
SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE
K003225 · Baxter Healthcare Corp · Oct 2000
LIFESHIELD ADDITIVE PIERCING PIN
K002006 · Abbott Laboratories · Aug 2000
COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET
K991985 · Cook, Inc. · Aug 1999