510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K900220Substantially Equivalent

Trans-Pace 100

Synchromed Corp., Cape Coral FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900220 is the FDA 510(k) clearance record for TRANS-PACE 100, a class II device, cleared for Synchromed Corp. on under FDA product code DTE (Pulse-Generator, Pacemaker, External). FDA records list one 510(k) clearance for Synchromed Corp. As of , FDA records show no recalls naming K900220.

Clearance record

Decision date
Received
(181 days to decision)
Product code
DTE Pulse-Generator, Pacemaker, External
Regulation
21 CFR 870.3600
Device class
Class II
Review panel
Cardiovascular
Applicant
Synchromed Corp. 2804 Del Prado Blvd., Cape Coral FL
Third party review
No

Clearances, product code DTE

Trailing 12 months

FDA records hold no clearances under product code DTE in the trailing twelve months.

FDA records show no clearances under product code DTE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DTE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260