Cleared Traditional

K012754 - EZ SET INFUSION SET

K012754 is an FDA 510(k) clearance for EZ SET INFUSION SET, manufactured by Animas Corp.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K012754 · Animas Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
11d
Days
Class 2
Risk

K012754 is an FDA 510(k) clearance for the EZ SET INFUSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Animas Corp. (Frazer, US). The FDA issued a Cleared decision on August 27, 2001 after a review of 11 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 - K012754

510(k) Number K012754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2001
Decision Date August 27, 2001
Days to Decision 11 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 129d · This submission: 11d
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

Citech
ROBERT MOSENKIS

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 1017
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K012754.
SIMPLICITY SOFT QD MICRO INFUSION SET
K012845 · Sterling Medivations, Inc. · Sep 2001
PRESSURE ACTIVATED CHECK VALVE
K011888 · Churchill Medical Systems, Inc. · Sep 2001
EXEL I.V. ADMINISTRATION SET
K010404 · Exelint Intl. Co. · Aug 2001
HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05
K011928 · Northgate Technologies, Inc. · Aug 2001
SIMPLICITY EURO QD INFUSION SET
K012330 · Sterling Medivations, Inc. · Aug 2001
PVC FREE INTRAVASCULAR ADMINISTRATION SET
K011216 · Biometrix , Ltd. · Jul 2001

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.

K012754 · EZ SET INFUSION SET
Download PDF FDA Summary Animas Corp.