Medical device manufacturer
Telectronics, Inc.
Telectronics, Inc. holds 107 FDA 510(k) clearances across 13 product codes. Median elapsed review time is 47 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 107
- Product codes
- 13
- Median review
- 47 days
- Recall records
- 0
How does FDA spell Telectronics, Inc.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Telectronics, Inc. file in?
13 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| DXY | Implantable Pacemaker Pulse-Generator | 47 | 42 days | |
| DTB | Permanent Pacemaker Electrode | 35 | 47 days | |
| DTD | Pacemaker Lead Adaptor | 8 | 104 days | |
| DTE | Pulse-Generator, Pacemaker, External | 3 | 66 days | |
| DYB | Introducer, Catheter | 3 | 35 days | |
| KRG | Programmer, Pacemaker | 2 | 33 days | |
| BXY | Flowmeter, Calibration, Gas | 1 | 29 days | |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 | 64 days | |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 53 days | |
| DSF | Recorder, Paper Chart | 1 | 53 days | |
| DSK | Computer, Blood-Pressure | 1 | 61 days | |
| DTC | Analyzer, Pacemaker Generator Function | 1 | 39 days | |
| DTF | Tools, Pacemaker Service | 1 | 13 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 Telectronics, Inc. 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 Telectronics, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K890895 | IMPLANTABLE ADAPTOR 033-380 | DTD | 377 | |
| K891231 | OPTIMA MPT AND SPT PACEMAKERS | DXY | 189 | |
| K890350 | VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE) | DTB | 86 | |
| K884411 | OPTIMA MPT AND SPT PACEMAKERS | DXY | 98 | |
| K884278 | IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436 | DTB | 64 | |
| K881837 | OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D | DXY | 77 | |
| K874664 | IMPLANTABLE ELECTRODE LEAD, MODEL 030-446 | DTB | 200 | |
| K864712 | MODEL 1740 PERSONAL POCKET PROGRAMMER | KRG | 379 | |
| K872766 | IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS | DXY | 113 | |
| K865098 | SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438 | DTB | 231 |
Source: openFDA device/510k · retrieved
Watch what Telectronics, Inc. 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.