Cleared Traditional

AB2 MED-FLO SOLUTION SET (K984569) - FDA 510(k) Clearance

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

K984569 · Ab2 Medical Products, Llp · General Hospital
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Aug 1999
Decision
232d
Days
Class 2
Risk

K984569 is an FDA 510(k) clearance for the AB2 MED-FLO SOLUTION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Ab2 Medical Products, Llp (The Woodlands, US). The FDA issued a Cleared decision on August 12, 1999 after a review of 232 days - an extended review 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: 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 Ab2 Medical Products, Llp devices

Submission Details

510(k) Number K984569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1998
Decision Date August 12, 1999
Days to Decision 232 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
103d slower than avg
Panel avg: 129d · This submission: 232d
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 225
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K984569.
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
BURETROL SOLUTION SETS
K984381 · Baxter Healthcare Corp · Feb 1999
ROWE DUAL-CHECK VALVE
K983217 · Cook, Inc. · Jan 1999