Cleared Special

HARVARD 2 SYRINGE PUMP, MODEL 2001-001 (K050107) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K050107 · Harvard Clinical Technology · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
24d
Days
Class 2
Risk

K050107 is an FDA 510(k) clearance for the HARVARD 2 SYRINGE PUMP, MODEL 2001-001. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Harvard Clinical Technology (South Natick, US). The FDA issued a Cleared decision on February 11, 2005 after a review of 24 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Harvard Clinical Technology devices

Submission Details

510(k) Number K050107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2005
Decision Date February 11, 2005
Days to Decision 24 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 129d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 220
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K050107.
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K
K052973 · Baxter Healthcare Corp · Jan 2007
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED CATHETER AND FLOW SPLITTER
K053226 · Zimmer, Inc. · Jan 2006
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM WITH PATIENT CONTROL MODULE
K052171 · Zimmer, Inc. · Oct 2005
PUMP CONNECTIVITY INTERFACE
K040985 · Baxter Healthcare Corp · Nov 2004
HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K041550 · Abbott Laboratories · Jun 2004
COLLEAGUE VOLUMETRIC INFUSION PUMPS
K041191 · Baxter Healthcare Corp · Jun 2004