Cleared Special

K052722 - LIFESHIELD LATEX-FREE MICROBORE EXTENSI...

K052722 is the FDA 510(k) clearance for LIFESHIELD LATEX-FREE MICROBORE EXTENSI... by Hospira, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Special 510(k) pathway after a 34-day FDA review.

K052722 · Hospira, Inc. · General Hospital
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Nov 2005
Decision
34d
Days
Class 2
Risk

K052722 is an FDA 510(k) clearance for the LIFESHIELD LATEX-FREE MICROBORE EXTENSION SET, MODEL 14949 AND OTHERS. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on November 2, 2005 after a review of 34 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 Hospira, Inc. devices

Submission Details

510(k) Number K052722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received September 29, 2005
Decision Date November 02, 2005
Days to Decision 34 days
Submission Type Special
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
95d faster than avg
Panel avg: 129d · This submission: 34d
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 373
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