Cleared Traditional

K032767 - LILY VOLUME METERIC ADMINISTRATION SET, MODELS IB-2111 AND CIB-120ES

K032767 is an FDA 510(k) clearance for LILY VOLUME METERIC ADMINISTRATION SET, manufactured by Lily Medical Supplies Co., Ltd.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K032767 · Lily Medical Supplies Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
272d
Days
Class 2
Risk

K032767 is an FDA 510(k) clearance for the LILY VOLUME METERIC ADMINISTRATION SET, MODELS IB-2111 AND CIB-120ES. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Lily Medical Supplies Co., Ltd. (Hsin Chu City, TW). The FDA issued a Cleared decision on June 3, 2004 after a review of 272 days - an extended review cycle.

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. Standard predicate reliance. 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.

View all Lily Medical Supplies Co., Ltd. devices

FDA 510(k) Submission Details - K032767

510(k) Number K032767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2003
Decision Date June 03, 2004
Days to Decision 272 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 129d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 729
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