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510(k) K241781

Solo Pace Control by Solo Pace, Inc. — Product Code DTE

K241781 is an FDA 510(k) premarket notification submitted by Solo Pace, Inc. for the device "Solo Pace Control". The FDA issued a decision of Substantially Equivalent on January 10, 2025. The device falls under product code DTE (Pulse-Generator, Pacemaker, External), a Class II device regulated under 21 CFR 870.3600. Solo Pace, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2025
Date Received
June 20, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pulse-Generator, Pacemaker, External
Device Class
Class II
Regulation Number
870.3600
Review Panel
CV
Submission Type

Other clearances by Solo Pace, Inc.

  • K252674 — Solo Pace Fusion System (SOLOFUSE1) (January 9, 2026)

Other clearances for product code DTE

  • K232721 — Lifetech Cardio Temporary Pacemaker (January 7, 2024)
  • K201011 — Medtronic Model 5392 External Pulse Generator (EPG) (May 13, 2020)
  • K190825 — Medtronic Model 5392 External Pulse Generator (EPG) (April 30, 2019)
  • K182839 — Lifetech Cardio Model 8301 Temporary Pacemaker (February 28, 2019)
  • K181973 — Medtronic Model 5392 External Pulse Generator (EPG) (August 21, 2018)
  • K180873 — Medtronic Model 53401 External Pulse Generator (EPG) (April 19, 2018)
  • K162054 — Medtronic Temporary External Pacemaker 53401 (October 18, 2016)
  • K162550 — Medtronic Model 5392 External Pulse Generator (EPG) (October 12, 2016)
  • K150246 — Medtronic Model 5392 External Pulse Generator (EPG) (February 18, 2015)
  • K132924 — MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) (October 31, 2013)

FDA data resources