Cleared Abbreviated

K000017 - PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET SECONDARY SECONDARY ADMINISTRATION SET, MODEL A1400

K000017 is an FDA 510(k) clearance for PARSET SECONDARY ADMINISTRATION SET, 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 38-day FDA review.

K000017 · Rd Medical Mfg., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
38d
Days
Class 2
Risk

K000017 is an FDA 510(k) clearance for the PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET SECONDAR.... Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Rd Medical Mfg., Inc. (Culebra, US). The FDA issued a Cleared decision on February 10, 2000 after a review of 38 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 - K000017

510(k) Number K000017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2000
Decision Date February 10, 2000
Days to Decision 38 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
91d faster than avg
Panel avg: 129d · This submission: 38d
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 762
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K000017.
CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090
K000942 · Sims Deltec, Inc. · Apr 2000
VENUSA, LTD. EXTENSION SET WITH FILTER
K994429 · Venusa , Ltd. · Mar 2000
EXEL INJECTION PLUG WITH CAP
K992290 · Exel Intl. · Feb 2000
MILLENNIUM HUBER PLUS SAFETY INFUSION SET
K993848 · Millennium Medical Distribution, Inc. · Jan 2000
INTRAVASCULAR ADMINISTRATION SET
K993463 · Custom Assemblies, Inc. · Jan 2000
DAISY PROTECTED SCALP VEIN SET
K992999 · Diasol, Inc. · Nov 1999