Cleared Special

K050107 - HARVARD 2 SYRINGE PUMP, MODEL 2001-001

K050107 is an FDA 510(k) clearance for HARVARD 2 SYRINGE PUMP, manufactured by Harvard Clinical Technology. The device is a Class 2 General Hospital device with product code FRN cleared through the Special 510(k) pathway after a 24-day FDA review.

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

FDA 510(k) Submission Details - K050107

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.

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 552
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K050107.
HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5
K052052 · Hospira, Inc. · Aug 2005
PAINPUMP2
K043466 · Stryker Instruments · May 2005
MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C
K043600 · Medtronic Minimed · Mar 2005
PHARMGUARD TOOLBOX, MODEL G6000782
K042432 · Medex, Inc. · Jan 2005
PUMP CONNECTIVITY INTERFACE
K040985 · Baxter Healthcare Corp · Nov 2004
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE
K042980 · Hospira, Inc. · Nov 2004