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)
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.

View all Spectrx, Inc. devices

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
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 548
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