FDA product code KRI: Accessory Equipment, Cardiopulmonary Bypass
KRI is the FDA product code for accessory equipment, cardiopulmonary bypass. It is a Class I device, regulated under 21 CFR 870.4200 and reviewed by the Cardiovascular panel. FDA has cleared 42 510(k) submissions under KRI, from 28 different applicants. The average 510(k) review took 66 days (median 50). FDA has posted 8 recalls for KRI devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Accessory Equipment, Cardiopulmonary Bypass |
| Device class | Class I |
| Regulation | 21 CFR 870.4200 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KRI clearance
Top KRI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Bentley | 7 | 1986-07-15 |
| Shiley, Inc. | 4 | 1987-02-19 |
| Texas Medical Products, Inc. | 3 | 1981-01-16 |
| Stoeckert Instrumente | 2 | 1999-12-20 |
| American Omni Medical, Inc. | 2 | 1989-01-30 |
23 more applicants have KRI clearances. See the full list in Caduvo.
Most recent KRI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K020365 | 3t Medical Systems, LLC | 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE | 2002-05-03 | 88 |
| K992635 | Stoeckert Instrumente | INTERFACE MODULE IDDD | 1999-12-20 | 136 |
| K990512 | Stoeckert Instrumente | STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS | 1999-11-23 | 278 |
| K934782 | Ammex Cardiopulmonary Corp. | AMMEX TUBING ORGANIZER | 1993-11-18 | 43 |
| K926233 | Ergometrix, Inc. | CARDIO2 CYCLE | 1993-06-04 | 175 |
Recalls for KRI devices
8 product recalls in 7 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-06-27.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2020 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code KRI?
KRI is the FDA product code for accessory equipment, cardiopulmonary bypass. It is a Class I device, regulated under 21 CFR 870.4200 and reviewed by the Cardiovascular panel.
What device class is KRI?
Class I, regulation 21 CFR 870.4200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KRI?
Across 42 cleared submissions the average was 66 days from receipt to decision (median 50).
Which companies have the most KRI clearances?
American Bentley (7); Shiley, Inc. (4); Texas Medical Products, Inc. (3); Stoeckert Instrumente (2); American Omni Medical, Inc. (2).
Have KRI devices been recalled?
Yes: 8 product recalls across 7 recall events; the most recent began 2025-06-27.
Next steps
- Run an FDA pathway report with predicate devices for product code KRI
- Run a recall and safety report across every KRI manufacturer
- Watch product code KRI 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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