Medical device manufacturer
Pacesetter Systems
Pacesetter Systems holds 96 FDA 510(k) clearances across 12 product codes. Median elapsed review time is 60 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 96
- Product codes
- 12
- Median review
- 60 days
- Recall records
- 0
How does FDA spell Pacesetter Systems?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Pacesetter Systems file in?
12 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| DTB | Permanent Pacemaker Electrode | 33 | 49 days | |
| DXY | Implantable Pacemaker Pulse-Generator | 28 | 78 days | |
| DTD | Pacemaker Lead Adaptor | 20 | 28 days | |
| FRN | Pump, Infusion | 7 | 53 days | |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 1 | 352 days | |
| DTG | Magnet, Test, Pacemaker | 1 | 26 days | |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 | 99 days | |
| DYB | Introducer, Catheter | 1 | 72 days | |
| FPA | Set, Administration, Intravascular | 1 | 130 days | |
| KNG | Monitor, Ultrasonic, Fetal | 1 | 68 days | |
| KRE | Analyzer, Pacemaker Generator Function, Indirect | 1 | 60 days | |
| KRG | Programmer, Pacemaker | 1 | 69 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Pacesetter Systems had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Pacesetter Systems cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K910924 | ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE | DTB | 176 | |
| K902147 | ENDOCARDIAL SCREW-IN LEAD MODEL 1028T | DTB | 63 | |
| K900512 | SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS | DTD | 143 | |
| K900550 | FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T | DTB | 73 | |
| K895447 | ENDOCARDIAL SCREW-IN LEAD MODEL 1020T | DTB | 103 | |
| K891905 | CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE | DTB | 70 | |
| K885267 | VS-1 MODEL NUMBER 251K PULSE GENERATOR | DXY | 96 | |
| K890547 | SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS | DTB | 47 | |
| K884733 | AFP MODEL 262T PULSE GENERATOR | DXY | 92 | |
| K883087 | PROLOG MP 658M PULSE GENERATOR | DXY | 55 |
Source: openFDA device/510k · retrieved
Watch what Pacesetter Systems files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.