Cleared Abbreviated

K010538 - PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PARSET NEEDLELESS SECONDARY SET WITH BLUNT CANNULA, A14003E

K010538 is an FDA 510(k) clearance for PARSET NEEDLELESS PRIMARY SET FOR BLUNT..., manufactured by Rd Medical Mfg., Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Abbreviated 510(k) pathway after a 35-day FDA review.

K010538 · Rd Medical Mfg., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
35d
Days
Class 2
Risk

K010538 is an FDA 510(k) clearance for the PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PARSET NEEDLELESS S.... Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Rd Medical Mfg., Inc. (Cuelbra, US). The FDA issued a Cleared decision on March 30, 2001 after a review of 35 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Rd Medical Mfg., Inc. devices

FDA 510(k) Submission Details - K010538

510(k) Number K010538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2001
Decision Date March 30, 2001
Days to Decision 35 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 129d · This submission: 35d
Pathway characteristics
Standards-based clearance path.

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 761
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K010538.
SIMPLICITY WINGED QD INFUSION SET
K010676 · Sterling Medivations, Inc. · Apr 2001
SIMPLICITY INFUSER INFUSION SET
K010647 · Sterling Medivations, Inc. · Apr 2001
SIMPLICITY SILVER SET SOFT INFUSION
K010846 · Sterling Medivations, Inc. · Apr 2001
SURSHIELD WINGED INFUSION SET
K010103 · Terumo Medical Corp. · Mar 2001
SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND MINIMED MEDICATION RESERVOIRS (MODEL MMT-103)
K010373 · Sterling Medivations, Inc. · Mar 2001
SWABSITE SWABBABLE VALVE, MODEL 245000
K002689 · Quest Medical, Inc. · Mar 2001