Cleared Traditional

K083583 - XPRESSE INJECTION SYSTEM

K083583 is an FDA 510(k) clearance for XPRESSE INJECTION SYSTEM, manufactured by Nordson Efd. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K083583 · Nordson Efd · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
208d
Days
Class 2
Risk

K083583 is an FDA 510(k) clearance for the XPRESSE INJECTION SYSTEM. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Nordson Efd (East Providence, US). The FDA issued a Cleared decision on June 30, 2009 after a review of 208 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 - K083583

510(k) Number K083583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2008
Decision Date June 30, 2009
Days to Decision 208 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
79d slower than avg
Panel avg: 129d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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.

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 - FMF Syringe, Piston

All 638
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K083583.
EASY.TOUCH INSULIN SYRINGE
K091474 · Masters Healthcare, LLC · Jul 2009
BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES
K083686 · Anhui Kangda Medical Products Co., Ltd. · Jul 2009
BD FLU+ SYRINGE
K091377 · Becton, Dickinson & CO · Jul 2009
STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE
K090929 · Shanghai Double Dove Industrial Co., Ltd. · Jun 2009
COVIDIEN EXTENDED TIP APPLICATOR
K091315 · Confluent Surgical,Inc · Jun 2009
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K083514 · Terumo Europe N.V. · May 2009

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.

K083583 · XPRESSE INJECTION SYSTEM
Download PDF FDA Summary Nordson Efd