Cleared Traditional

K080660 - IV ADMINISTRATION SET

K080660 is an FDA 510(k) clearance for IV ADMINISTRATION SET, manufactured by U.S. Safety Syringes Co., Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K080660 · U.S. Safety Syringes Co., Inc. · General Hospital
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May 2008
Decision
64d
Days
Class 2
Risk

K080660 is an FDA 510(k) clearance for the IV ADMINISTRATION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by U.S. Safety Syringes Co., Inc. (Crofton, US). The FDA issued a Cleared decision on May 13, 2008 after a review of 64 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. 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.

FDA 510(k) Submission Details - K080660

510(k) Number K080660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2008
Decision Date May 13, 2008
Days to Decision 64 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 129d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FPA Set, Administration, Intravascular

All 1024
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FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K080660 · IV ADMINISTRATION SET
Download PDF U.S. Safety Syringes …