FDA product code · Cardiovascular
DXYImplantable Pacemaker Pulse-Generator
Product code DXY covers Implantable Pacemaker Pulse-Generator, a Class III device regulated under 21 CFR 870.3610. FDA has cleared 461 devices in this code. Median review time across the 461 most recent decisions is 56 days. openFDA lists 75 recall records against this code.
Updated · ingest status · JSON
- Class
- Class III
- Regulation
- 21 CFR 870.3610
- Review panel
- Cardiovascular
- Clearances
- 461
What is happening in DXY right now?
DXY (Implantable Pacemaker Pulse-Generator): nothing changed in the six FDA sources we watch.
Checked predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Nothing changed, so there is nothing here — which is the point. We only write when something did.
How many devices has FDA cleared in DXY?
FDA has cleared 461 devices under product code DXY since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K993434 | PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A | Biotronik, Inc. | |
| K970072 | OPUS S MODEL 4121 AND 4124 PACEMAKERS | Ela Medical, Inc. | |
| K945627 | PIKOS LP 01, PIKOS LP E01 | Biotronik, Inc. | |
| K954092 | ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION) | Medtronic Vascular | |
| K953866 | MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION) | Medtronic Vascular | |
| K953417 | MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS | Cook Pacemaker Corp. | |
| K952328 | NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 | Biotronik, Inc. | |
| K952364 | OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) | Ela Medical, Inc. | |
| K940039 | PELLETHANE 75D | Medtronic Vascular | |
| K950751 | TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES | Medtronic Vascular |
How long does FDA review take for DXY?
The median FDA review time for DXY is 56 days, measured across the 461 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in DXY?
openFDA lists 75 recall records against product code DXY. A recall record covers one firm's corrective action and may span many device lots.
Z-1495-2022Open, ClassifiedSt. Jude Medical, Cardiac Rhythm Management Division
There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.
Z-1496-2022Open, ClassifiedSt. Jude Medical, Cardiac Rhythm Management Division
The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.
Z-1497-2022Open, ClassifiedSt. Jude Medical, Cardiac Rhythm Management Division
The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.
Z-0030-2018TerminatedSt. Jude Medical, Inc.
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Z-0031-2018TerminatedSt. Jude Medical, Inc.
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Showing the 5 most recently initiated of 75. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for DXY?
MAUDE holds 2,506 adverse-event reports naming product code DXY, 561 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in DXY unusual?
One month sits above DXY's own expected range: 1 April 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 40 | Insufficient history | No expected range — too little history | |
| 46 | Insufficient history | No expected range — too little history | |
| 31 | Insufficient history | No expected range — too little history | |
| 40 | Insufficient history | No expected range — too little history | |
| 54 | Insufficient history | No expected range — too little history | |
| 47 | Insufficient history | No expected range — too little history | |
| 47 | Insufficient history | No expected range — too little history | |
| 266 | Insufficient history | No expected range — too little history | |
| 67 | Insufficient history | No expected range — too little history | |
| 61 | Insufficient history | No expected range — too little history | |
| 59 | Insufficient history | No expected range — too little history | |
| 60 | Insufficient history | No expected range — too little history | |
| 59 | Insufficient history | No expected range — too little history | |
| 52 | Insufficient history | No expected range — too little history | |
| 63 | Insufficient history | No expected range — too little history | |
| 71 | Insufficient history | No expected range — too little history | |
| 76 | Insufficient history | No expected range — too little history | |
| 50 | Insufficient history | No expected range — too little history | |
| 97 | Insufficient history | No expected range — too little history | |
| 65 | Insufficient history | No expected range — too little history | |
| 60 | Insufficient history | No expected range — too little history | |
| 64 | 42–80 | Within expected (42–80) | |
| 36 | 37–70 | Below expected (37–70) | |
| 69 | 32–76 | Within expected (32–76) | |
| 92 | 37–84 | Above expected (37–84) | |
| 75 | 38–93 | Within expected (38–93) | |
| 51 | 43–100 | Within expected (43–100) | |
| 81 | 56–149 | Within expected (56–149) | |
| 64 | 36–109 | Within expected (36–109) | |
| 67 | 35–112 | Within expected (35–112) | |
| 66 | 35–108 | Within expected (35–108) | |
| 50 | 33–93 | Within expected (33–93) | |
| 80 | 30–100 | Within expected (30–100) | |
| 95 | 40–121 | Within expected (40–121) | |
| 61 | 37–106 | Within expected (37–106) | |
| 99 | 40–111 | Within expected (40–111) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in DXY.
What are the predicate devices in DXY?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in DXY?
Across the 461 most recent decisions, these applicants filed most often in DXY.
| Applicant | Recent clearances |
|---|---|
| Medtronic Vascular | 59 |
| Intermedics, Inc. | 52 |
| Telectronics, Inc. | 47 |
| Cardiac Pacemakers, Inc. | 37 |
| Pacesetter Systems | 28 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch DXY
Get an email the morning anything changes in DXY — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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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.