Cleared Traditional

K984638 - PARAGON BOLUS ACCESSORY SET

K984638 is an FDA 510(k) clearance for PARAGON BOLUS ACCESSORY SET, manufactured by I-Flow Corp.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K984638 · I-Flow Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
40d
Days
Class 2
Risk

K984638 is an FDA 510(k) clearance for the PARAGON BOLUS ACCESSORY SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by I-Flow Corp. (Lake Forest, US). The FDA issued a Cleared decision on February 9, 1999 after a review of 40 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 I-Flow Corp. devices

FDA 510(k) Submission Details - K984638

510(k) Number K984638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1998
Decision Date February 09, 1999
Days to Decision 40 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
89d faster than avg
Panel avg: 129d · This submission: 40d
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 532
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K984638.
CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER
K990083 · Sims Deltec, Inc. · Feb 1999
PARAGON BASAL/BOLUS ADMINISTRATION SET
K984063 · I-Flow Corp. · Feb 1999
PARAGON INFUSION
K984146 · I-Flow Corp. · Feb 1999
ROWE DUAL-CHECK VALVE
K983217 · Cook, Inc. · Jan 1999
COLLEAGUE PUMP SYRINGE ADAPTER SET
K982672 · Baxter Healthcare Corp · Sep 1998
SOLUTION ADMINISTRATION SET
K981792 · Baxter Healthcare Corp · Aug 1998