FDA product code SDJ: Adjunctive Cardiac Amyloidosis Status Indicator
SDJ is the FDA product code for adjunctive cardiac amyloidosis status indicator. It is a Class II device, regulated under 21 CFR 870.2200 and reviewed by the Cardiovascular panel. FDA has cleared 3 510(k) submissions under SDJ, 3 in the last five years, from 3 different applicants. The average 510(k) review took 179 days (median 155); 192 days on average over the last three years.
Definition
The adjunctive cardiac amyloidosis status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting cardiac amyloidosis. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
Classification
| Field | Value |
|---|---|
| Device name | Adjunctive Cardiac Amyloidosis Status Indicator |
| Device class | Class II |
| Regulation | 21 CFR 870.2200 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for SDJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 232 |
| 2025 | 2 | 152 |
Compare with all 510(k) review times · Search every SDJ clearance
Top SDJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Eko.Ai Pte Ltd. D/B/A Us2.Ai | 1 | 2025-06-20 |
| InVision Medical Technology Corporation | 1 | 2025-05-21 |
| Ultromics Limited | 1 | 2024-11-15 |
Most recent SDJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250151 | Eko.Ai Pte Ltd. D/B/A Us2.Ai | Us2.ca | 2025-06-20 | 150 |
| K243866 | InVision Medical Technology Corporation | InVision Precision Cardiac Amyloid | 2025-05-21 | 155 |
| K240860 | Ultromics Limited | EchoGo Amyloidosis (1.0) | 2024-11-15 | 232 |
Recalls for SDJ devices
openFDA lists no recalls for product code SDJ.
Frequently asked questions
What is FDA product code SDJ?
SDJ is the FDA product code for adjunctive cardiac amyloidosis status indicator. It is a Class II device, regulated under 21 CFR 870.2200 and reviewed by the Cardiovascular panel.
What device class is SDJ?
Class II, regulation 21 CFR 870.2200. Typical premarket route: 510(k).
How long does a 510(k) take for product code SDJ?
Across 3 cleared submissions the average was 179 days from receipt to decision (median 155).
Which companies have the most SDJ clearances?
Eko.Ai Pte Ltd. D/B/A Us2.Ai (1); InVision Medical Technology Corporation (1); Ultromics Limited (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SDJ
- Run a recall and safety report across every SDJ manufacturer
- Watch product code SDJ 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.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times