FDA product code KDQ: Bottle, Collection, Vacuum
KDQ is the FDA product code for bottle, collection, vacuum. It is a Class II device, regulated under 21 CFR 880.6740 and reviewed by the General Hospital panel. FDA has cleared 48 510(k) submissions under KDQ, from 32 different applicants. The average 510(k) review took 65 days (median 46). FDA has posted 33 recalls for KDQ devices, 15 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Bottle, Collection, 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 KDQ clearance
Top KDQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Atrium Medical Corp. | 8 | 2008-07-25 |
| Deknatel, Inc. | 5 | 1996-08-28 |
| Davol, Inc. | 2 | 1993-07-13 |
| Boehringer Laboratories | 2 | 1986-04-28 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 2 | 1985-12-27 |
27 more applicants have KDQ clearances. See the full list in Caduvo.
Most recent KDQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K081718 | Atrium Medical Corp. | EXPRESS CHEST DRAIN | 2008-07-25 | 37 |
| K062302 | Millicore AB | MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM | 2006-10-06 | 59 |
| K043582 | Atrium Medical Corp. | OCEAN CHEST DRAIN | 2005-01-21 | 24 |
| K984496 | Atrium Medical Corp. | ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN | 1999-05-05 | 139 |
| K962856 | Deknatel, Inc. | PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR | 1996-08-28 | 37 |
Recalls for KDQ devices
33 product recalls in 20 recall events; 15 initiated in the last five years and 17 still open. Most recent: 2024-06-27.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 4 |
| 2024 | 8 |
Frequently asked questions
What is FDA product code KDQ?
KDQ is the FDA product code for bottle, collection, vacuum. It is a Class II device, regulated under 21 CFR 880.6740 and reviewed by the General Hospital panel.
What device class is KDQ?
Class II, regulation 21 CFR 880.6740. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KDQ?
Across 48 cleared submissions the average was 65 days from receipt to decision (median 46).
Which companies have the most KDQ clearances?
Atrium Medical Corp. (8); Deknatel, Inc. (5); Davol, Inc. (2); Boehringer Laboratories (2); Bd Becton Dickinson Vacutainer Systems Preanalytic (2).
Have KDQ devices been recalled?
Yes: 33 product recalls across 20 recall events; the most recent began 2024-06-27.
Next steps
- Run an FDA pathway report with predicate devices for product code KDQ
- Run a recall and safety report across every KDQ manufacturer
- Watch product code KDQ 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.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times