FDA product code KRK: Manometer, Blood-Pressure, Venous
KRK is the FDA product code for manometer, blood-pressure, venous. It is a Class II device, regulated under 21 CFR 870.1140 and reviewed by the Cardiovascular panel. FDA has cleared 9 510(k) submissions under KRK, from 8 different applicants. The average 510(k) review took 69 days (median 47). FDA has posted 2 recalls for KRK devices.
Classification
| Field | Value |
|---|---|
| Device name | Manometer, Blood-Pressure, Venous |
| Device class | Class II |
| Regulation | 21 CFR 870.1140 |
| 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 KRK clearance
Top KRK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Burron Medical Products, Inc. | 2 | 1982-01-07 |
| Aloka Co., Ltd. | 1 | 1995-09-15 |
| Medex, Inc. | 1 | 1990-12-27 |
| Ethitek Pharmaceuticals Co. | 1 | 1989-01-05 |
| Schneider-Shilley (Usa) | 1 | 1988-03-28 |
3 more applicants have KRK clearances. See the full list in Caduvo.
Most recent KRK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K950607 | Aloka Co., Ltd. | UST-5268P-5 TRANSDUCER | 1995-09-15 | 218 |
| K904674 | Medex, Inc. | CENTRAL VENOUS PRESSURE MANOMETER | 1990-12-27 | 76 |
| K884386 | Ethitek Pharmaceuticals Co. | ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK | 1989-01-05 | 79 |
| K875322 | Schneider-Shilley (Usa) | MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER | 1988-03-28 | 90 |
| K861605 | Shiley, Inc. | SCHNEIDER-SHILEY PRESSURE MANOMETER | 1986-05-28 | 29 |
Recalls for KRK devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-02-23.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code KRK?
KRK is the FDA product code for manometer, blood-pressure, venous. It is a Class II device, regulated under 21 CFR 870.1140 and reviewed by the Cardiovascular panel.
What device class is KRK?
Class II, regulation 21 CFR 870.1140. Typical premarket route: 510(k).
How long does a 510(k) take for product code KRK?
Across 9 cleared submissions the average was 69 days from receipt to decision (median 47).
Which companies have the most KRK clearances?
Burron Medical Products, Inc. (2); Aloka Co., Ltd. (1); Medex, Inc. (1); Ethitek Pharmaceuticals Co. (1); Schneider-Shilley (Usa) (1).
Have KRK devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2017-02-23.
Next steps
- Run an FDA pathway report with predicate devices for product code KRK
- Run a recall and safety report across every KRK manufacturer
- Watch product code KRK 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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