Atlas FDA

Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)

FDA 510(k) clearance K251745 · decided 2025-12-16

Clearance details

K-number
K251745
Device name
Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
Applicant
Baxter Healthcare Corporation
Decision
Substantially Equivalent
Date received
2025-06-06
Decision date
2025-12-16
Days to decision
193 days
Clearance type
Traditional
Product code
DXQ
Device class
2
Regulation number
870.1120
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Deerfield Lake, 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
Medline Reusable Blood Pressure Cuff (K254287)Medline Industries, LP2026-06-22
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Disposable Neonatal NIBP Cuff (U1681S-C51N) (K253964)Unimed Medical Supplies, Inc.2026-01-09
AViTA Arm Type Blood Pressure Monitor Cuff (K250765)Avita Corporation2025-09-03
Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N) (K251045)Unimed Medical Supplies, Inc.2025-07-15
Disposable Blood Pressure cuff; Reusable Blood Pressure cuff (K242623)Shenzhen Medke Technology Co., Ltd.2024-10-31
Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer (K240165)Wenzhou Longwan Medical Device Factory2024-03-20
Reusable Blood Pressure Cuff (K233276)Suzhou Minhua Medical Apparatus Supplies Co., Ltd.2023-12-21
Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,1207D1-2#,1207D1-3#,1207D1-4#,1207D1-5#,1201B1,12L2B1,1202B1,12L3B1,1203B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,,1207B1-3#,1207B1-4#,1207B1-5#,1201W2,12L2W2,1202W2,12L3W2,1203W2,1204W2,1205W2,1206W2 and 1207W2) (K232772)Shenzhen Plinma Technology Co. , Ltd.2023-11-29
NIBPCuff (K231961)Shenzhen Sino-K Medical Technology Co.,Ltd2023-08-30
Aneroid Sphygmomanometer (K230859)Wenzhou Kangshun Medical Devices Co.,Ltd2023-06-28

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
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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