510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983196Substantially Equivalent

Padtak Pace/defib/cardiovert Monitoring Electrode(s)

TZ Medical Inc., Lake Oswego OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983196 is the FDA 510(k) clearance record for PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S), a class II device, cleared for Tz Medical, Inc. on under FDA product code DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)). FDA records list 15 510(k) clearances for Tz Medical, Inc., from to . As of , FDA records show one recall naming K983196.

Clearance record

Decision date
Received
(369 days to decision)
Product code
DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Regulation
21 CFR 870.5550
Device class
Class II
Review panel
Cardiovascular
Applicant
Tz Medical, Inc. 15858 SW Upper Boones Ferry Rd., Lake Oswego OR
510(k) summary
Statement
Third party review
No

Clearances, product code DRO

Trailing 12 months

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

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