Cleared Traditional

K091441 - SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET

K091441 is an FDA 510(k) clearance for SYNERGETICS ADJUSTABLE GAS PRESSURIZED ..., manufactured by Synergetics, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K091441 · Synergetics, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
168d
Days
Class 2
Risk

K091441 is an FDA 510(k) clearance for the SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Synergetics, Inc. (O' Fallon, US). The FDA issued a Cleared decision on October 30, 2009 after a review of 168 days - an extended review cycle.

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.

View all Synergetics, Inc. devices

FDA 510(k) Submission Details - K091441

510(k) Number K091441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2009
Decision Date October 30, 2009
Days to Decision 168 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
39d slower than avg
Panel avg: 129d · This submission: 168d
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 548
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K091441.
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
K112067 · Carticept Medical, Inc. · Sep 2011
MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)
K111386 · Smiths Medical MD, Inc. · Aug 2011
MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C
K100798 · Medrad, Inc. · Jun 2010
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
K083689 · B.Braun Medical, Inc. · Jul 2009
THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000
K091855 · Belmont Instrument Corp. · Jul 2009
POWER INFUSER, MODEL M100B-3A
K090736 · ZOLL Medical Corporation · May 2009