FDA product code IYY: Synchronizer, Electrocardiograph, Nuclear
IYY is the FDA product code for synchronizer, electrocardiograph, nuclear. It is a Class I device, regulated under 21 CFR 892.1410 and reviewed by the Radiology panel. FDA has cleared 3 510(k) submissions under IYY, from 3 different applicants. The average 510(k) review took 77 days (median 51).
Classification
| Field | Value |
|---|---|
| Device name | Synchronizer, Electrocardiograph, Nuclear |
| Device class | Class I |
| Regulation | 21 CFR 892.1410 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IYY clearance
Top IYY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Capintec, Inc. | 1 | 1986-02-13 |
| Amr Co. | 1 | 1979-03-22 |
| Bios, Inc. | 1 | 1978-04-18 |
Most recent IYY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K853737 | Capintec, Inc. | VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM) | 1986-02-13 | 160 |
| K790213 | Amr Co. | GENERATOR, R-WAVE | 1979-03-22 | 51 |
| K780510 | Bios, Inc. | NUCLEAR STETHOSCOPE | 1978-04-18 | 19 |
Recalls for IYY devices
openFDA lists no recalls for product code IYY.
Frequently asked questions
What is FDA product code IYY?
IYY is the FDA product code for synchronizer, electrocardiograph, nuclear. It is a Class I device, regulated under 21 CFR 892.1410 and reviewed by the Radiology panel.
What device class is IYY?
Class I, regulation 21 CFR 892.1410. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IYY?
Across 3 cleared submissions the average was 77 days from receipt to decision (median 51).
Which companies have the most IYY clearances?
Capintec, Inc. (1); Amr Co. (1); Bios, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IYY
- Run a recall and safety report across every IYY manufacturer
- Watch product code IYY 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 Radiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times