Cleared Traditional

K090917 - SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM

K090917 is an FDA 510(k) clearance for SURECONNECT CLOSED DRUG RECONSTITUTION ..., manufactured by Baxa Corp.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K090917 · Baxa Corp. · General Hospital
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Feb 2010
Decision
324d
Days
Class 2
Risk

K090917 is an FDA 510(k) clearance for the SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Baxa Corp. (Englewood, US). The FDA issued a Cleared decision on February 19, 2010 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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. Elevated predicate reliance profile. 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 - K090917

510(k) Number K090917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2009
Decision Date February 19, 2010
Days to Decision 324 days
Submission Type Traditional
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
195d slower than avg
Panel avg: 129d · This submission: 324d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHI Device Classification - Class 2, Special Controls

Product Code LHI Set, I.v. Fluid Transfer
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 - LHI Set, I.v. Fluid Transfer

All 189
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K090917.
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K092246 · Nipro Medical Corporation · Nov 2009
K090917 · SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
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