FDA product code DXY: Implantable Pacemaker Pulse-Generator
DXY is the FDA product code for implantable pacemaker pulse-generator. It is a Class III device, regulated under 21 CFR 870.3610 and reviewed by the Cardiovascular panel. FDA has cleared 461 510(k) submissions under DXY, from 48 different applicants. The average 510(k) review took 80 days (median 56). 20 PMA applications cite this product code. FDA has posted 75 recalls for DXY devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Implantable Pacemaker Pulse-Generator |
| Device class | Class III |
| Regulation | 21 CFR 870.3610 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | PMA |
| Implant | Yes |
Compare with all 510(k) review times · Search every DXY clearance
Top DXY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic Vascular | 59 | 1995-12-15 |
| Intermedics, Inc. | 52 | 1992-03-17 |
| Telectronics, Inc. | 47 | 1989-09-12 |
| Cardiac Pacemakers, Inc. | 37 | 1992-10-28 |
| Pacesetter Systems | 28 | 1989-03-28 |
43 more applicants have DXY clearances. See the full list in Caduvo.
Most recent DXY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K993434 | Biotronik, Inc. | PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A | 1999-11-10 | 29 |
| K970072 | Ela Medical, Inc. | OPUS S MODEL 4121 AND 4124 PACEMAKERS | 1997-08-29 | 233 |
| K945627 | Biotronik, Inc. | PIKOS LP 01, PIKOS LP E01 | 1996-03-04 | 474 |
| K954092 | Medtronic Vascular | ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION) | 1995-12-15 | 127 |
| K953866 | Medtronic Vascular | MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION) | 1995-12-15 | 127 |
Recalls for DXY devices
75 product recalls in 16 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2022-06-17.
| Year | Recalls |
|---|---|
| 2017 | 4 |
| 2022 | 3 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- C1767 — Generator, neurostimulator (implantable), non-rechargeable
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system
- C8009 — Removal of hypoglossal nerve neurostimulator array and pulse generator
- C7540 — Removal of permanent pacemaker pulse generator with replacement of pacemaker pulse generator, dual lead system, with insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (eg, for upgrade to dual chamber system)
- C7538 — Insertion of new or replacement of permanent pacemaker with ventricular transvenous electrode(s), with insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (e.g., for upgrade to dual chamber system)
Frequently asked questions
What is FDA product code DXY?
DXY is the FDA product code for implantable pacemaker pulse-generator. It is a Class III device, regulated under 21 CFR 870.3610 and reviewed by the Cardiovascular panel.
What device class is DXY?
Class III, regulation 21 CFR 870.3610. Typical premarket route: PMA.
How long does a 510(k) take for product code DXY?
Across 461 cleared submissions the average was 80 days from receipt to decision (median 56).
Which companies have the most DXY clearances?
Medtronic Vascular (59); Intermedics, Inc. (52); Telectronics, Inc. (47); Cardiac Pacemakers, Inc. (37); Pacesetter Systems (28).
Have DXY devices been recalled?
Yes: 75 product recalls across 16 recall events; the most recent began 2022-06-17.
Next steps
- Run an FDA pathway report with predicate devices for product code DXY
- Run a recall and safety report across every DXY manufacturer
- Watch product code DXY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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