510(k) clearances

Sensinel Cardiopulmonary Management (CPM) System

Analog Devices · Cardiovascular

K260801Substantially EquivalentTraditionalMWI
Open FDA's page for this record
Third party flag
N
City
Wilmington
Advisory committee description
Cardiovascular
Address 1
1 Analog Way
Statement or summary
Summary
Product code
MWI
Zip code
01887
Applicant
Analog Devices
Decision date
2026-10-16
Decision code
SESE
Country code
US
Device name
Sensinel Cardiopulmonary Management (CPM) System
Advisory committee
CV
Contact
Sam Rajkumar
K number
K260801
State
MA
Date received
2026-03-11
Review advisory committee
CV
Postal code
01887
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Medical specialty description
Cardiovascular
Regulation number
870.2300
Device class
2
Registration number
3033959233, 3018094310, 3010399798, 9611348, 3013298431, 3008729547, 1222630, 3008716327, 3003768277, 3003589956, 3009499478, 3010824458, 3007134734, 3007137598, 3012103976, 3016852448, 3003681187, 3021632375, 3035111606, 1054713, 3010390468, 2027454, 3016674095, 3007029079, 3008977358, 3009156722, 3004009431, 3007413079, 3016618143, 3011651230, 3012359877, 3005569927, 3013896610, 3014856521, 1066427, 8040564, 3006606827, 3043543260, 3042175844, 3004091281 +136 more
FEI number
3033959233, 3018094310, 3010399798, 3013298431, 3008729547, 3008716327, 3003589956, 3009499478, 3010824458, 1000292048, 3007134734, 3007137598, 3012103976, 3016852448, 3003681187, 3021632375, 3035111606, 3010390468, 3000957797, 2027454, 3016674095, 3007029079, 3008977358, 3009156722, 3004009431, 3007413079, 3016618143, 3011651230, 3012359877, 3005569927, 3013896610, 3014856521, 3006606827, 3043543260, 3042175844, 3027256461, 2221819, 3004188066, 3003971136, 3006254866 +136 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.