Cleared Traditional

K955709 - WINGED & SUBCUTANEOUS INFUSION SETS

K955709 is an FDA 510(k) clearance for WINGED & SUBCUTANEOUS INFUSION SETS, manufactured by Distronic Sterile Products, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K955709 · Distronic Sterile Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
65d
Days
Class 2
Risk

K955709 is an FDA 510(k) clearance for the WINGED & SUBCUTANEOUS INFUSION SETS. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Distronic Sterile Products, Inc. (Portsmouth, US). The FDA issued a Cleared decision on February 21, 1996 after a review of 65 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.

View all Distronic Sterile Products, Inc. devices

FDA 510(k) Submission Details - K955709

510(k) Number K955709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1995
Decision Date February 21, 1996
Days to Decision 65 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
64d faster than avg
Panel avg: 129d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - FPA Set, Administration, Intravascular

All 749
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K955709.
MAXCESS NEEDLE FREE CONNECTOR (8200)
K960661 · Solopak Medical Products, Inc. · Mar 1996
ANGIOFLUSH II FLUID MANAGEMENT SYSTEM
K953825 · AngioDynamics, Inc. · Feb 1996
POLYFIN QR SUBCUTANEOUS INFUSION SET
K954969 · Medtronic Minimed · Feb 1996
VENTED SOLUTION SET
K955732 · Distronic Sterile Products, Inc. · Feb 1996
NIMA (NEEDLELESS INJECTIONSITE MASTER ADAPTER) & I.V. SET
K952852 · Critical Device Corp. · Feb 1996
VLV SA.EF INFUSION PORT EXTENSION SETS
K955783 · Vlv Associates, Inc. · Feb 1996