# Pacesetter Systems

- Location (FDA's records): Mchenry, IL
- FDA decisions: 98 (1976–1991): 96 510(k) clearances and 2 original PMA approvals
- Product codes: DTB (33), DXY (28), DTD (20), FRN (7), LWP (2), DYB (1), DSY (1), DXH (1), KNG (1), KRG (1), FPA (1), DTG (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Medtronic Minimed: 2 (https://510kreport.com/company/medtronic-minimed)
- Cyberonics, Inc.: 1 (https://510kreport.com/company/cyberonics)

## Its most-cited devices
- K861436: Sof Set, Models 111 and 112 (1986), cited by 1
- K831445: Infusion Sets #'S 124 & 142 Personal (1983), cited by 1
- K813153: Test Magnet (1981), cited by 1

## Recent decisions
- K910924: Endocardial Leads-Mod. to the Polyvinylpyrrolidone (Aug 28, 1991)
- K902147: Endocardial Screw-in Lead Model 1028T (Jul 17, 1990)
- K900512: Siemens Elema Models 4020T and 4021T Adapters (Jun 25, 1990)
- K900550: Fast-Pass Ace Models 1212T/1222T/1216T/1226T (Apr 20, 1990)
- K895447: Endocardial Screw-in Lead Model 1020T (Dec 20, 1989)
- K891905: Cardiovascular Permanent Pacemaker Electrode (Jun 5, 1989)
- K885267: VS-1 Model Number 251K Pulse Generator (Mar 28, 1989)
- K890547: Siemens Elema Models 4025 and 4026 Adapters (Mar 22, 1989)

Source page: https://510kreport.com/company/pacesetter-systems