Atlas FDA

t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater

FDA 510(k) clearance K162080 · decided 2016-10-25

Clearance details

K-number
K162080
Device name
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
Applicant
Tandem Diabetes Care, Inc.
Decision
Substantially Equivalent
Date received
2016-07-27
Decision date
2016-10-25
Days to decision
90 days
Clearance type
Traditional
Product code
LZG
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
San Diego, CA, 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
Pivot Insulin Delivery System (K253534)Modular Medical2026-04-08
Modular Medical MODD1 Insulin Delivery System (K240158)Modular Medical, Inc.2024-09-04
Extended Reservoir; MiniMed Reservoir (K241622)Medtronic Minimed2024-07-02
Omnipod GO Insulin Delivery Device (K223372)Insulet Corporation2023-04-24
Extended Reservoir (K210714)Medtronic Minimed, Inc.2022-04-06
Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System (K211575)Insulet Corporation2021-08-13
Omnipod Insulin Management System, Omnipod DASH Insulin Management System (K192659)Insulet Corporation2019-10-21
Omnipod Insulin Management System, Omnipod DASH Insulin Management System (K182630)Insulet Corporation2019-01-08
Omnipod DASH Insulin Management System (K180045)Insulet Corporation2018-06-01
OmniPod Insulin Management System (K162296)Insulet Corporation2017-04-18
t:slim Insulin Delivery System (K160056)Tandem Diabetes Care, Inc.2016-07-25
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater (K160482)Tandem Diabetes Care, Inc.2016-07-13

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System (P140015/S029)Tandem Diabetes Care, Inc.2019-12-19
t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S007)Tandem Diabetes Care, Inc.2019-12-19
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System (P140015/S028)Tandem Diabetes Care, Inc.2019-03-01
t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S002)Tandem Diabetes Care, Inc.2018-11-29
t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S003)Tandem Diabetes Care, Inc.2018-11-29
t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S001)Tandem Diabetes Care, Inc.2018-11-29
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM (P140015/S027)Tandem Diabetes Care, Inc.2018-10-26
t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S006)Tandem Diabetes Care, Inc.2018-10-26