# Ela Medical, Inc.

- Location (FDA's records): Minnetonka, MN
- FDA decisions: 43 (1979–2004): 43 510(k) clearances
- Product codes: DXY (22), DTB (11), DQK (3), DTC (2), MWJ (1), ELA (1), DSI (1)
- Predicates its devices cite: 26 (11 its own); citations of its devices by later devices: 18 (11 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Elamedical: 2 (https://510kreport.com/company/elamedical)
- International Biophysics Corp.: 2 (https://510kreport.com/company/international-biophysics)
- Rozinn Electronics, Inc.: 2 (https://510kreport.com/company/rozinn-electronics)
- Braemar, Inc.: 2 (https://510kreport.com/company/braemar)
- Burdick Corp.: 2 (https://510kreport.com/company/burdick)
- Mortara Instrument, Inc.: 1 (https://510kreport.com/company/mortara-instrument)
- North East Monitoring, Inc.: 1 (https://510kreport.com/company/north-east-monitoring)
- Medical Graphics Corp.: 1 (https://510kreport.com/company/medical-graphics)

## Firms that cite its devices most
- Novacor: 2 (https://510kreport.com/company/novacor)
- Memtec Corp.: 1 (https://510kreport.com/company/memtec)
- Mortara Instrument, Inc.: 1 (https://510kreport.com/company/mortara-instrument)
- Brentwood Medical Technology Corp.: 1 (https://510kreport.com/company/brentwood-medical-technology)
- Cardiocalm Srl: 1 (https://510kreport.com/company/cardiocalm)
- Labtech Kft.: 1 (https://510kreport.com/company/labtech-kft)

## Its most-cited devices
- K032466: Spiderview (2003), cited by 4
- K990727: Syneflash & Syneview (1999), cited by 3
- K896742: Focus J81F, J83F, J41F, J43F Pacing Leads (1990), cited by 2
- K002817: Synetec (2001), cited by 2
- K972574: Stela Model UJ45 Pacing Leads (1998), cited by 1
- K042002: Synescope, Easyscope, Synecom, Holterreader (2004), cited by 1

## Recent decisions
- K042002: Synescope, Easyscope, Synecom, Holterreader (Oct 20, 2004)
- K032466: Spiderview (Aug 22, 2003)
- K002817: Synetec (May 2, 2001)
- K993448: Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped Tined Pacing Leads (Apr 10, 2000)
- K000029: Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped Tined Pacing Leads (Apr 4, 2000)
- K990727: Syneflash & Syneview (Nov 26, 1999)
- K972574: Stela Model UJ45 Pacing Leads (Jan 8, 1998)
- K970072: Opus S Model 4121 and 4124 Pacemakers (Aug 29, 1997)

Source page: https://510kreport.com/company/ela-medical