Cleared Traditional

K043204 - SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP

K043204 is an FDA 510(k) clearance for SGARLATO LABS PAINFREE PUMP AND PAIN CO..., manufactured by Sgarlato Laboratories, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K043204 · Sgarlato Laboratories, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
132d
Days
Class 2
Risk

K043204 is an FDA 510(k) clearance for the SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Sgarlato Laboratories, Inc. (Campbell, US). The FDA issued a Cleared decision on March 30, 2005 after a review of 132 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K043204

510(k) Number K043204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2004
Decision Date March 30, 2005
Days to Decision 132 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
3d slower than avg
Panel avg: 129d · This submission: 132d
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 761
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K043204.
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K043600 · Medtronic Minimed · Mar 2005
SE INFUSION SYSTEM WITH MMS
K043590 · Cardinal Health, Alaris Products · Mar 2005
MRIDIUM 3850 MRI PUMP SYSTEM
K050301 · Iradimed Corporation · Mar 2005
K043204 · SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP
Download PDF FDA Summary Sgarlato Laboratories…