Ela Medical, Inc.: FDA filings under this applicant name
FDA lists 43 510(k) clearances under the applicant name “Ela Medical, Inc.” (first 1979, latest 2004), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 106 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 | 22 | 22 |
| DTB | Permanent Pacemaker Electrode | 11 | 11 |
| DQK | Computer, Diagnostic, Programmable | 3 | 3 |
| DTC | Analyzer, Pacemaker Generator Function | 2 | 2 |
| DSI | Detector And Alarm, Arrhythmia | 1 | 1 |
| ELA | Instrument, Hand, Calculus Removal | 1 | 1 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 1 | 1 |
Plus 1 more product codes.
Review panels
- Cardiovascular (40)
- Dental (1)
Most recent Ela Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042002 | SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER | DQK | 2004-10-20 | 86 |
| K032466 | SPIDERVIEW | MWJ | 2003-08-22 | 11 |
| K002817 | SYNETEC | DQK | 2001-05-02 | 233 |
| K993448 | STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS | DTB | 2000-04-10 | 181 |
| K000029 | STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS | DTB | 2000-04-04 | 90 |
| K990727 | SYNEFLASH & SYNEVIEW | DQK | 1999-11-26 | 266 |
| K972574 | STELA MODEL UJ45 PACING LEADS | DTB | 1998-01-08 | 182 |
| K970072 | OPUS S MODEL 4121 AND 4124 PACEMAKERS | DXY | 1997-08-29 | 233 |
| K963738 | STELA MODEL BJ44 AND BJ45 PACING LEADS | DTB | 1997-05-23 | 248 |
| K952364 | OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) | DXY | 1995-09-01 | 123 |
33 earlier clearances. See the full list in Caduvo.
Recalls
11 product recalls in 7 recall events; 0 initiated in the last five years. Most recent: 2011-05-02.
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.
Device clinical trials
An industry sponsor named Ela Medical, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00957541: Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device (Completed, started 2009-09)
- NCT00586378: Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study (Completed, started 2006-04)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Ela Medical, 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)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ela Medical, Inc.?
FDA lists 43 510(k) clearances under the applicant name “Ela Medical, Inc.” (first 1979, latest 2004), across 8 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 Ela Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ela Medical, Inc. is 106 days.
Which FDA product codes appear under Ela Medical, Inc.?
The most frequent FDA product codes under this applicant name are DXY (Implantable Pacemaker Pulse-Generator, 22); DTB (Permanent Pacemaker Electrode, 11); DQK (Computer, Diagnostic, Programmable, 3).
Next steps
- See all 43 Ela Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXY, Ela Medical, 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.