FDA product code KRB: Probe, Thermodilution
KRB is the FDA product code for probe, thermodilution. It is a Class II device, regulated under 21 CFR 870.1915 and reviewed by the Cardiovascular panel. FDA has cleared 37 510(k) submissions under KRB, from 28 different applicants. The average 510(k) review took 90 days (median 61). FDA has posted 4 recalls for KRB devices.
Classification
| Field | Value |
|---|---|
| Device name | Probe, Thermodilution |
| Device class | Class II |
| Regulation | 21 CFR 870.1915 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KRB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 264 |
Compare with all 510(k) review times · Search every KRB clearance
Top KRB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gould, Inc. | 4 | 1984-05-23 |
| Instrumentation Laboratory CO | 3 | 1976-07-21 |
| Pulsion Medical Systems AG | 2 | 2007-09-19 |
| Andover Medical, Inc. | 2 | 1984-11-20 |
| American Edwards Laboratories | 2 | 1981-06-12 |
23 more applicants have KRB clearances. See the full list in Caduvo.
Most recent KRB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K171620 | Pulsion Medical Systems SE | PiCCO Catheter | 2018-02-21 | 264 |
| K100739 | Edwards Lifesciences, LLC | VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 | 2010-12-07 | 266 |
| K072364 | Pulsion Medical Systems AG | PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES | 2007-09-19 | 28 |
| K020587 | Pulsion Medical Systems AG | PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046 | 2002-05-23 | 90 |
| K991886 | Pulsion Medical Systems, Inc. | PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR | 2000-05-11 | 344 |
Recalls for KRB devices
4 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-10-05.
| Year | Recalls |
|---|---|
| 2018 | 3 |
Frequently asked questions
What is FDA product code KRB?
KRB is the FDA product code for probe, thermodilution. It is a Class II device, regulated under 21 CFR 870.1915 and reviewed by the Cardiovascular panel.
What device class is KRB?
Class II, regulation 21 CFR 870.1915. Typical premarket route: 510(k).
How long does a 510(k) take for product code KRB?
Across 37 cleared submissions the average was 90 days from receipt to decision (median 61).
Which companies have the most KRB clearances?
Gould, Inc. (4); Instrumentation Laboratory CO (3); Pulsion Medical Systems AG (2); Andover Medical, Inc. (2); American Edwards Laboratories (2).
Have KRB devices been recalled?
Yes: 4 product recalls across 2 recall events; the most recent began 2018-10-05.
Next steps
- Run an FDA pathway report with predicate devices for product code KRB
- Run a recall and safety report across every KRB manufacturer
- Watch product code KRB 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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