Cleared Traditional

K020786 - INJEX NEEDLE-FREE INJECTION SYSTEM

Also marketed or referenced as:
ROJEX NEEDLE-FREE INJECTION SYSTEM

K020786 is an FDA 510(k) clearance for INJEX NEEDLE-FREE INJECTION SYSTEM, manufactured by Rosch AG Medizintechnic. The device is a Class 2 General Hospital device with product code KZE cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K020786 · Rosch AG Medizintechnic · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
198d
Days
Class 2
Risk

K020786 is an FDA 510(k) clearance for the INJEX NEEDLE-FREE INJECTION SYSTEM. Classified as Injector, Fluid, Non-electrically Powered (product code KZE), Class II - Special Controls.

Submitted by Rosch AG Medizintechnic (Berlin, DE). The FDA issued a Cleared decision on September 25, 2002 after a review of 198 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5430 - 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.

FDA 510(k) Submission Details - K020786

510(k) Number K020786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2002
Decision Date September 25, 2002
Days to Decision 198 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
69d slower than avg
Panel avg: 129d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KZE Device Classification - Class 2, Special Controls

Product Code KZE Injector, Fluid, Non-electrically Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5430
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

Tuv America, Inc.

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 - KZE Injector, Fluid, Non-electrically Powered

All 51
Devices cleared under the same product code (KZE) and FDA review panel - the closest regulatory comparables to K020786.
HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500
K041280 · Felton International, Inc. · Jun 2004
BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001
K032976 · Biovalve Technologies, Inc. · Apr 2004
AVANT GUARDIAN 101
K024018 · Avant Medical Corporation · Jan 2003
INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000
K022502 · Equidyne Systems, Inc. · Sep 2002
INJEX 30 NEEDLE FREE INJECTION SYSTEM
K022148 · Equidyne Systems, Inc. · Jul 2002
BI-3M NEEDLE-FREE INJECTOR SYSTEM
K013256 · Felton International, Inc. · Dec 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.

K020786 · INJEX NEEDLE-FREE INJECTION SYSTEM
Download PDF FDA Summary Rosch AG Medizintechn…