Cleared Traditional

K032789 - REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469

K032789 is an FDA 510(k) clearance for REPLACEMENT PUMP HEAD DOOR ASSEMBLY, manufactured by American I.V. Products, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K032789 · American I.V. Products, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
31d
Days
Class 2
Risk

K032789 is an FDA 510(k) clearance for the REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD.... Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by American I.V. Products, Inc. (Hanover, US). The FDA issued a Cleared decision on October 9, 2003 after a review of 31 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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.

FDA 510(k) Submission Details - K032789

510(k) Number K032789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2003
Decision Date October 09, 2003
Days to Decision 31 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
98d faster than avg
Panel avg: 129d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 657
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K032789.
INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE
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K033325 · Sorenson Medical, Inc. · Nov 2003
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BEELINE SYSTEM
K032642 · Mckinley, Inc. · Sep 2003
MEDRAD CONTINUUM MR INFUSION SYSTEM
K032771 · Medrad, Inc. · Sep 2003
MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332
K032005 · Medtronic Minimed · Aug 2003