DROClass II

Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

21 CFR 870.5550 / Cardiovascular

DRO is the FDA product code for Pacemaker, Cardiac, External Transcutaneous (Non-Invasive), a class II device type, regulated under 21 CFR 870.5550. As of 2026-09-10, FDA records hold 84 510(k) clearances under this code, the most recent dated 2001-10-12, and 22 recalls.

Classification record

Product code: DRO
Device name: Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Regulation: 21 CFR 870.5550
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: Yes
GMP exempt: No
Third party review eligible: No
Ingested clearances: 84
Ingested recalls: 22

Clearances, product code DRO

By decision year

84 clearances under product code DRO with a decision year between 1982 and 2001, 1987 the highest year at 15.

Show the numbers

510(k) clearances under FDA product code DRO by decision year
Year	Clearances
1982	6
1984	6
1985	9
1986	10
1987	15
1988	12
1989	6
1990	1
1991	3
1992	3
1993	1
1995	3
1996	1
1997	2
1998	1
1999	2
2000	1
2001	2

Applicants with the most clearances

Product code DRO

Applicants holding the most 510(k) clearances under product code DRO
Applicant	Clearances
Cardiac Resucitator Corp.	13
Physio Control, Inc.	10
Cardiotronics, Inc.	9
Medac, Inc.	8
Katecho LLC	4
Medical Data Electronics	3
Andover Medical, Inc.	2
Conmedcorp	2
Darox Corp.	2
Hewlett-Packard Co.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order