510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K897116Substantially Equivalent

Optima Mpt Model 5281E and Model 5282E

Telectronics Pacing Systems, Inc., Englewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K897116 is the FDA 510(k) clearance record for OPTIMA MPT MODEL 5281E AND MODEL 5282E, a class III device, cleared for Telectronics Pacing Systems, Inc. on under FDA product code DXY (Implantable Pacemaker Pulse-Generator). FDA records list 20 510(k) clearances for Telectronics Pacing Systems, Inc., from to . As of , FDA records show no recalls naming K897116.

Clearance record

Decision date
Received
(78 days to decision)
Product code
DXY Implantable Pacemaker Pulse-Generator
Regulation
21 CFR 870.3610
Device class
Class III
Review panel
Cardiovascular
Applicant
Telectronics Pacing Systems, Inc. 7400 S. Tucson Way, Englewood CO
Third party review
No

Clearances, product code DXY

Trailing 12 months

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

FDA records show no clearances under product code DXY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DXY, 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