FDA product code KDP: Regulator, Vacuum
KDP is the FDA product code for regulator, vacuum. It is a Class II device, regulated under 21 CFR 880.6740 and reviewed by the General Hospital panel. FDA has cleared 21 510(k) submissions under KDP, from 15 different applicants. The average 510(k) review took 79 days (median 62). FDA has posted 4 recalls for KDP devices.
Classification
| Field | Value |
|---|---|
| Device name | Regulator, Vacuum |
| Device class | Class II |
| Regulation | 21 CFR 880.6740 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KDP clearance
Top KDP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boehringer Laboratories | 4 | 2002-01-08 |
| Precision Medical, Inc. | 2 | 1994-12-22 |
| Sorensen Research | 2 | 1983-07-12 |
| Harris-Lake, Inc. | 2 | 1976-08-04 |
| Engineered Orthopedic Technologies, Inc. | 1 | 1994-07-21 |
10 more applicants have KDP clearances. See the full list in Caduvo.
Most recent KDP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K013976 | Boehringer Laboratories | BOEHRINGER MRI SUCTION REGULATORY | 2002-01-08 | 36 |
| K944479 | Precision Medical, Inc. | PM3300 INTERMITTENT VACUUM | 1994-12-22 | 100 |
| K942747 | Engineered Orthopedic Technologies, Inc. | MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) ) | 1994-07-21 | 41 |
| K933232 | Boehringer Laboratories | BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED | 1994-03-28 | 265 |
| K926140 | Hill-Rom, Inc. | VACUUM POWER BODY FLUID SUCTION APPARATUS | 1993-07-27 | 232 |
Recalls for KDP devices
4 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-03-12.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code KDP?
KDP is the FDA product code for regulator, vacuum. It is a Class II device, regulated under 21 CFR 880.6740 and reviewed by the General Hospital panel.
What device class is KDP?
Class II, regulation 21 CFR 880.6740. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KDP?
Across 21 cleared submissions the average was 79 days from receipt to decision (median 62).
Which companies have the most KDP clearances?
Boehringer Laboratories (4); Precision Medical, Inc. (2); Sorensen Research (2); Harris-Lake, Inc. (2); Engineered Orthopedic Technologies, Inc. (1).
Have KDP devices been recalled?
Yes: 4 product recalls across 2 recall events; the most recent began 2018-03-12.
Next steps
- Run an FDA pathway report with predicate devices for product code KDP
- Run a recall and safety report across every KDP manufacturer
- Watch product code KDP 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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