510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884522Substantially Equivalent

Model 5650 Optimate Personal Programmer

Teletronics, Inc., Suffield CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884522 is the FDA 510(k) clearance record for MODEL 5650 OPTIMATE PERSONAL PROGRAMMER, a class III device, cleared for Teletronics, Inc. on under FDA product code KRG (Programmer, Pacemaker). FDA records list one 510(k) clearance for Teletronics, Inc. As of , FDA records show no recalls naming K884522.

Clearance record

Decision date
Received
(302 days to decision)
Product code
KRG Programmer, Pacemaker
Regulation
21 CFR 870.3700
Device class
Class III
Review panel
Cardiovascular
Applicant
Teletronics, Inc. Attorney-At-Law, Suffield CT
Third party review
No

Clearances, product code KRG

Trailing 12 months

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

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