Cleared Traditional

Deltaven Fast Flash Closed I.V. Catheter Systems (K200373) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200373 · Delta Med Spa · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
194d
Days
Class 2
Risk

K200373 is an FDA 510(k) clearance for the Deltaven Fast Flash Closed I.V. Catheter Systems. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Delta Med Spa (Viadana, IT). The FDA issued a Cleared decision on August 26, 2020 after a review of 194 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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.

View all Delta Med Spa devices

Submission Details

510(k) Number K200373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2020
Decision Date August 26, 2020
Days to Decision 194 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 129d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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

Donawa Lifescience Consulting Srl
Roger Gray

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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 503
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K200373.
Introcan Safety® Deep Access XL IV Catheter
K253235 · B.Braun Medical, Inc. · May 2026
BD Insyte™ IV Catheter
K252137 · Becton Dickinson Infusion Therapy Systems, Inc. · Apr 2026
Polywin Safety (14G x 51mm
K252513 · Poly Medicure Limited · Apr 2026
SURFLO Hybria Closed System Safety IV Catheter
K252398 · Terumo Medical Products Hangzhou Co., Ltd. · Dec 2025
Polyshield Safety IV Catheters
K252677 · Poly Medicure Limited · Nov 2025
BD Saf-T-Intima™ Subcutaneous Catheter System
K251422 · Becton Dickinson Infusion Therapy Systems, Inc. · Oct 2025