FDA product code KRL: Detector, Bubble, Cardiopulmonary Bypass
KRL is the FDA product code for detector, bubble, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4205 and reviewed by the Cardiovascular panel. FDA has cleared 14 510(k) submissions under KRL, from 10 different applicants. The average 510(k) review took 93 days (median 78). FDA has posted 4 recalls for KRL devices.
Classification
| Field | Value |
|---|---|
| Device name | Detector, Bubble, Cardiopulmonary Bypass |
| Device class | Class II |
| Regulation | 21 CFR 870.4205 |
| 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 KRL clearance
Top KRL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Rocky Mountain Research, Inc. | 2 | 1996-10-31 |
| 3M Health Care, Sarns | 2 | 1994-05-24 |
| Sorin Biomedica, Fiat, USA, Inc. | 2 | 1993-05-18 |
| Cobe Laboratories, Inc. | 2 | 1986-07-18 |
| Sorin Group Deutschland GmbH | 1 | 2011-01-18 |
5 more applicants have KRL clearances. See the full list in Caduvo.
Most recent KRL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K103469 | Sorin Group Deutschland GmbH | STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 | 2011-01-18 | 55 |
| K090698 | Terumo Cardiovascular Systems | CAPIOX BUBBLE TRAP WITH X-COATING | 2009-06-08 | 83 |
| K071231 | Luna Innovations, Inc. | EDAC QUANTIFIER | 2007-05-17 | 14 |
| K961364 | Rocky Mountain Research, Inc. | AUTOMATIC TUBING CLAMP SYSTEM (ATC) | 1996-10-31 | 205 |
| K961598 | Rocky Mountain Research, Inc. | ELS AUTOMATIC TUBING CLAMP SYSTEM | 1996-10-29 | 203 |
Recalls for KRL devices
4 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-10-15.
Frequently asked questions
What is FDA product code KRL?
KRL is the FDA product code for detector, bubble, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4205 and reviewed by the Cardiovascular panel.
What device class is KRL?
Class II, regulation 21 CFR 870.4205. Typical premarket route: 510(k).
How long does a 510(k) take for product code KRL?
Across 14 cleared submissions the average was 93 days from receipt to decision (median 78).
Which companies have the most KRL clearances?
Rocky Mountain Research, Inc. (2); 3M Health Care, Sarns (2); Sorin Biomedica, Fiat, USA, Inc. (2); Cobe Laboratories, Inc. (2); Sorin Group Deutschland GmbH (1).
Have KRL devices been recalled?
Yes: 4 product recalls across 2 recall events; the most recent began 2010-10-15.
Next steps
- Run an FDA pathway report with predicate devices for product code KRL
- Run a recall and safety report across every KRL manufacturer
- Watch product code KRL 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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