Telectronics, Inc.: FDA filings under this applicant name
FDA lists 107 510(k) clearances under the applicant name “Telectronics, Inc.” (first 1977, latest 1990), plus 1 PMA decision, across 15 product codes in 2 review panels. Median 510(k) review time under this name: 47 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXY | Implantable Pacemaker Pulse-Generator | 47 | 47 |
| DTB | Permanent Pacemaker Electrode | 35 | 35 |
| DTD | Pacemaker Lead Adaptor | 8 | 8 |
| DTE | Pulse-Generator, Pacemaker, External | 3 | 3 |
| DYB | Introducer, Catheter | 3 | 3 |
| KRG | Programmer, Pacemaker | 2 | 2 |
| BXY | Flowmeter, Calibration, Gas | 1 | 1 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| DSF | Recorder, Paper Chart | 1 | 1 |
Plus 5 more product codes.
Review panels
- Cardiovascular (105)
- Anesthesiology (1)
Most recent Telectronics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K890895 | IMPLANTABLE ADAPTOR 033-380 | DTD | 1990-03-06 | 377 |
| K891231 | OPTIMA MPT AND SPT PACEMAKERS | DXY | 1989-09-12 | 189 |
| K890350 | VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE) | DTB | 1989-02-02 | 86 |
| K884411 | OPTIMA MPT AND SPT PACEMAKERS | DXY | 1989-01-26 | 98 |
| K884278 | IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436 | DTB | 1988-12-15 | 64 |
| K881837 | OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D | DXY | 1988-07-18 | 77 |
| K874664 | IMPLANTABLE ELECTRODE LEAD, MODEL 030-446 | DTB | 1988-05-31 | 200 |
| K864712 | MODEL 1740 PERSONAL POCKET PROGRAMMER | KRG | 1987-12-17 | 379 |
| K872766 | IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS | DXY | 1987-11-04 | 113 |
| K865098 | SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438 | DTB | 1987-08-18 | 231 |
97 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P850027 | PMA | TELECTRONICS PASAR MODEL 4171 PG | 1986-09-30 |
Recalls
openFDA lists no recalls under a recalling firm named Telectronics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Telectronics, Inc. (a text match, not an official crosswalk):
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via DXY)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via DXY)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Telectronics Pacing Systems, Inc. (20 510(k)s)
- Telectronics and Cordis Pacing Systems (3 510(k)s)
- Telectronics and Control Pacing Systems (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Telectronics, Inc.?
FDA lists 107 510(k) clearances under the applicant name “Telectronics, Inc.” (first 1977, latest 1990), plus 1 PMA decision, across 15 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Telectronics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Telectronics, Inc. is 47 days.
Which FDA product codes appear under Telectronics, Inc.?
The most frequent FDA product codes under this applicant name are DXY (Implantable Pacemaker Pulse-Generator, 47); DTB (Permanent Pacemaker Electrode, 35); DTD (Pacemaker Lead Adaptor, 8).
Next steps
- See all 107 Telectronics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXY, Telectronics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.