Cleared Special

K051045 - SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30

K051045 is an FDA 510(k) clearance for SIMPLECHOICE 3.0 ML RESERVOIR PRO REFER..., manufactured by Spectrx, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Special 510(k) pathway after a 99-day FDA review.

K051045 · Spectrx, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
99d
Days
Class 2
Risk

K051045 is an FDA 510(k) clearance for the SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Spectrx, Inc. (Norcross, US). The FDA issued a Cleared decision on August 2, 2005 after a review of 99 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K051045

510(k) Number K051045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2005
Decision Date August 02, 2005
Days to Decision 99 days
Submission Type Special
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
30d faster than avg
Panel avg: 129d · This submission: 99d
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 761
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K051045.
CRONO SUPER PID
K052217 · Cane S.R.L. · Sep 2005
CRONO GO.
K052219 · Cane S.R.L. · Sep 2005
HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5
K052052 · Hospira, Inc. · Aug 2005
MICROPUMP MP-101
K051252 · Micrel Medical Devices S.A. · May 2005
PAINPUMP2
K043466 · Stryker Instruments · May 2005
INFPUMP INFILTRATION PUMP
K050324 · Carolina Medical, Inc. · Apr 2005
K051045 · SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30
Download PDF FDA Summary Spectrx, Inc.