Atlas FDA

SOLUTION SET/EXTENSION SET

FDA 510(k) clearance K142011 · decided 2014-08-18

Clearance details

K-number
K142011
Device name
SOLUTION SET/EXTENSION SET
Applicant
Baxter Healthcare Corporation
Decision
Substantially Equivalent
Date received
2014-07-24
Decision date
2014-08-18
Days to decision
25 days
Clearance type
Special
Product code
FPA
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Round Lake, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Baxter Healthcare Corporation

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
iiSure Infusion Set (K261530)Deka Research and Development2026-06-03
AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04) (K252543)Amsino International, Inc.2026-05-04
PuraCath Firefly Needleless Connector IT (9005) (K251375)Puracath Medical, Inc.2026-02-12
nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] (K251257)Np Medical2025-12-04
BD Alaris Pump Infusion Set (K250325)Carefusion (Bd)2025-10-30
EZ™ IV Administration Set (K251814)Epic Medical Pte. , Ltd.2025-08-29
SteadiSet infusion set (K251854)Tandem Diabetes Care2025-08-06
Sparta Infusion Set for Insulin (K243841)Deka Research and Development2025-08-01
Infusomat® Space Volumetric Infusion Pump Administration Sets (K243392)B.Braun Medical, Inc.2025-07-24
Clave™ Neutral-Displacement Needlefree Connectors (K250616)Icu Medical, Inc.2025-06-05
SteadiSet Infusion Set (K242692)Capillary Biomedical, LLC2025-05-09
JetCan® Pro Safety Huber Needle (K242763)Pfm Medical, Inc.2025-05-02

Recalls involving this device

No recalls on record reference this clearance.

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