FDA product code KRC: Tester, Electrode, Surface, Electrocardiographic
KRC is the FDA product code for tester, electrode, surface, electrocardiographic. It is a Class II device, regulated under 21 CFR 870.2370 and reviewed by the Cardiovascular panel. FDA has cleared 11 510(k) submissions under KRC, from 10 different applicants. The average 510(k) review took 117 days (median 61).
Classification
| Field | Value |
|---|---|
| Device name | Tester, Electrode, Surface, Electrocardiographic |
| Device class | Class II |
| Regulation | 21 CFR 870.2370 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every KRC clearance
Top KRC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Circadian, Inc. | 2 | 1987-11-23 |
| Sontra Medical, Inc. | 1 | 2004-01-28 |
| E.B.S., Inc. | 1 | 1987-12-07 |
| Marquette Electronics, Inc. | 1 | 1987-11-23 |
| Aequitron Medical, Inc. | 1 | 1984-10-30 |
5 more applicants have KRC clearances. See the full list in Caduvo.
Most recent KRC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K023713 | Sontra Medical, Inc. | SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000 | 2004-01-28 | 450 |
| K872370 | E.B.S., Inc. | BIOMA 3500 | 1987-12-07 | 171 |
| K874327 | Marquette Electronics, Inc. | SKIN PREP ANALYZER | 1987-11-23 | 33 |
| K874155 | Circadian, Inc. | CIRCAMED MONITOR REMOTE START CONDUCTANCE METER | 1987-11-23 | 41 |
| K840358 | Aequitron Medical, Inc. | IMPEDANCE/8200 MONITOR-MODEL 8300 | 1984-10-30 | 278 |
Recalls for KRC devices
openFDA lists no recalls for product code KRC.
Frequently asked questions
What is FDA product code KRC?
KRC is the FDA product code for tester, electrode, surface, electrocardiographic. It is a Class II device, regulated under 21 CFR 870.2370 and reviewed by the Cardiovascular panel.
What device class is KRC?
Class II, regulation 21 CFR 870.2370. Typical premarket route: 510(k).
How long does a 510(k) take for product code KRC?
Across 11 cleared submissions the average was 117 days from receipt to decision (median 61).
Which companies have the most KRC clearances?
Circadian, Inc. (2); Sontra Medical, Inc. (1); E.B.S., Inc. (1); Marquette Electronics, Inc. (1); Aequitron Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KRC
- Run a recall and safety report across every KRC manufacturer
- Watch product code KRC 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.
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