510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K855015Substantially Equivalent

Noninvasive Temp. Pacemaker Ntp-1000

Zmi Corp., Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K855015 is the FDA 510(k) clearance record for NONINVASIVE TEMP. PACEMAKER NTP-1000, a class II device, cleared for Zmi Corp. on under FDA product code DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)). FDA records list 2 510(k) clearances for Zmi Corp., from to . As of , FDA records show no recalls naming K855015.

Clearance record

Decision date
Received
(105 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
Zmi Corp. 325 Vassar St., Cambridge MA
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