Cleared Traditional

K030032 - CROSSEAL APPLICATION DEVICE

K030032 is an FDA 510(k) clearance for CROSSEAL APPLICATION DEVICE, manufactured by Omrix Biopharmaceuticals, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K030032 · Omrix Biopharmaceuticals, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
77d
Days
Class 2
Risk

K030032 is an FDA 510(k) clearance for the CROSSEAL APPLICATION DEVICE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Omrix Biopharmaceuticals, Inc. (Warrington, US). The FDA issued a Cleared decision on March 21, 2003 after a review of 77 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Omrix Biopharmaceuticals, Inc. devices

FDA 510(k) Submission Details - K030032

510(k) Number K030032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2003
Decision Date March 21, 2003
Days to Decision 77 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
52d faster than avg
Panel avg: 129d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 425
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K030032.
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