Cleared Traditional

ACTI-FLEX IV ADMINISTRATION SET (K001599) - FDA 510(k) Clearance

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

K001599 · R-Group Intl. · General Hospital
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Sep 2000
Decision
117d
Days
Class 2
Risk

K001599 is an FDA 510(k) clearance for the ACTI-FLEX IV ADMINISTRATION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by R-Group Intl. (Gainesville, US). The FDA issued a Cleared decision on September 18, 2000 after a review of 117 days - within the typical 510(k) review window.

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: 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 R-Group Intl. devices

Submission Details

510(k) Number K001599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2000
Decision Date September 18, 2000
Days to Decision 117 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 129d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 239
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K001599.
SURSHIELD SAFETY WINGED BLOOD COLLECTION SET
K013164 · Terumo Medical Corp. · Oct 2001
SURSHIELD WINGED INFUSION SET
K010103 · Terumo Medical Corp. · Mar 2001
SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE
K003225 · Baxter Healthcare Corp · Oct 2000
LIFESHIELD ADDITIVE PIERCING PIN
K002006 · Abbott Laboratories · Aug 2000
COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET
K991985 · Cook, Inc. · Aug 1999
LUER ACCESS INJECTION SITE
K984060 · Baxter Healthcare Corp · Jul 1999