Cleared Traditional

K021700 - ANIMUS EZSERTER INFUSION SET INSERTER

K021700 is an FDA 510(k) clearance for ANIMUS EZSERTER INFUSION SET INSERTER, manufactured by Animas Corp.. The device is a Class 2 General Hospital device with product code KZH cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K021700 · Animas Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
12d
Days
Class 2
Risk

K021700 is an FDA 510(k) clearance for the ANIMUS EZSERTER INFUSION SET INSERTER. Classified as Introducer, Syringe Needle (product code KZH), Class II - Special Controls.

Submitted by Animas Corp. (Frazer, US). The FDA issued a Cleared decision on June 4, 2002 after a review of 12 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6920 - 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 - K021700

510(k) Number K021700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2002
Decision Date June 04, 2002
Days to Decision 12 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
117d faster than avg
Panel avg: 129d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KZH Device Classification - Class 2, Special Controls

Product Code KZH Introducer, Syringe Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6920
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 - KZH Introducer, Syringe Needle

All 40
Devices cleared under the same product code (KZH) and FDA review panel - the closest regulatory comparables to K021700.
INNOJECT AUTO-INJECTOR
K042557 · Innoject, Inc. · Nov 2004
MEDSAFE SYSTEM INSERTER
K032848 · Medsolve Technologies, LLC · Apr 2004
INVISIJECT RESUSABLE AUTO-INJECTOR
K032425 · Biogen · Nov 2003
AUTOJECT 2
K013362 · Owen Mumford USA, Inc. · Nov 2001
MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385
K010377 · Minimed, Inc. · Apr 2001
MODIFICATION TO AUTOJECT MINI
K000482 · Owen Mumford, Ltd. · Mar 2000

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.

K021700 · ANIMUS EZSERTER INFUSION SET INSERTER
Download PDF FDA Summary Animas Corp.