Atlas FDA

INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES

FDA 510(k) clearance K062457 · decided 2006-09-21

Clearance details

K-number
K062457
Device name
INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES
Applicant
Baxter Healthcare Corporation
Decision
Substantially Equivalent
Date received
2006-08-23
Decision date
2006-09-21
Days to decision
29 days
Clearance type
Special
Product code
MEB
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Mcgaw Park, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
SMARTeZ™ Elastomeric Infusion Pump (RS series) (K250234)Epic Medical Pte. , Ltd.2026-04-24
InfuLife (K240624)First Medical Source, LLC2024-11-05
SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) (K242152)Epic Medical Pte. , Ltd.2024-10-07
ON-Q* Pump with Bolus (K181360)Halyard Health2019-03-22
SMARTez elastomeric infusion pump (K151650)Epic Medical Pte. , Ltd.2016-04-04
ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES (K131249)I-Flow, LLC2014-02-03
MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM (K131247)Mfs - Medical Flow Systems, Ltd.2013-08-14
MODIFICATION TO AUTOFUSER (K090300)Ace Medical Us, LLC2009-04-30
ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP (K081905)Westmed, Inc.2008-07-15
ALPHA INFUSION PUMP, MODEL A200, A450 (K071532)Advanced Infusion, Inc.2008-02-19
DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM (K072921)Symbios Medical Products, LLC2007-11-26
SMARTBLOCK PAIN PUMP (K072053)Medical Flow Systems, Ltd.2007-11-06

Recalls involving this device

RecordFirmDate
Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor recall (Z-1609-2013)Baxter Healthcare Corp.2013-06-27
Baxter Single Day INFUSOR Portable Elastomeric Infusion System, Product Code: 2C1071KJP; 2 recall (Z-0588-2008)Baxter Healthcare Corp.2008-01-23

PMA approvals by this applicant

RecordFirmDate
Preveleak Surgical Sealant (P100030/S021)Baxter Healthcare Corporation2025-07-10
PerClot® Polysaccharide Hemostatic System (P210036/S005)Baxter Healthcare Corporation2025-04-25
Preveleak Surgical Sealant 4mL; Preveleak Delivery Tips 10 PK (P100030/S020)Baxter Healthcare Corporation2025-04-11
PerClot Polysaccharide Hemostatic System (P210036/S002)Baxter Healthcare Corporation2024-12-20
Seprafilm Adhesion Barrier (P950034/S059)Baxter Healthcare Corporation2024-12-19
PerClot Polysaccharide Hemostatic System (P210036/S004)Baxter Healthcare Corporation2024-07-18
Seprafilm Adhesion Barrier (P950034/S058)Baxter Healthcare Corporation2024-07-03
Preveleak Surgical Sealant, Preveleak 10-Pack delivery Tips (P100030/S019)Baxter Healthcare Corporation2024-06-06