Atlas FDA

Solo Pace Control

FDA 510(k) clearance K241781 · decided 2025-01-10

Clearance details

K-number
K241781
Device name
Solo Pace Control
Applicant
Solo Pace, Inc.
Decision
Substantially Equivalent
Date received
2024-06-20
Decision date
2025-01-10
Days to decision
204 days
Clearance type
Traditional
Product code
DTE
Device class
2
Regulation number
870.3600
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Petaluma, CA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Solo Pace

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
Lifetech Cardio Temporary Pacemaker (K232721)Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.2024-01-07
Medtronic Model 5392 External Pulse Generator (EPG) (K201011)Medtronic, Inc.2020-05-13
Medtronic Model 5392 External Pulse Generator (EPG) (K190825)Medtronic, Inc.2019-04-30
Lifetech Cardio Model 8301 Temporary Pacemaker (K182839)Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.2019-02-28
Medtronic Model 5392 External Pulse Generator (EPG) (K181973)Medtronic, Inc.2018-08-21
Medtronic Model 53401 External Pulse Generator (EPG) (K180873)Medtronic, Inc.2018-04-19
Medtronic Temporary External Pacemaker 53401 (K162054)Medtronic, Inc.2016-10-18
Medtronic Model 5392 External Pulse Generator (EPG) (K162550)Medtronic, Inc.2016-10-12
Medtronic Model 5392 External Pulse Generator (EPG) (K150246)Medtronic, Inc.2015-02-18
MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) (K132924)Medtronic, Inc.2013-10-31
PSA SERIES (K123916)Osypka Medical, Inc.2013-04-09
ERA 3000 PACING SYSTEM ANALYZER (K042708)Biotronik, Inc.2004-10-20

Recalls involving this device

No recalls on record reference this clearance.