510(k) · Cleared
ClearedMillicore AB Digivent Chest Drainage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Millicore AB · KDQ Bottle, Collection, Vacuum
Cleared on Oct 6, 2006 as substantially equivalent to K984496 (Atrium Medical Corp., 1999) and 1 other predicate after a 59-day review. Its family tree reaches back 2 generations to 1980.
- Decided
- Oct 6, 2006
- Review
- 59 days
- Class
- Class II
- Product code
- KDQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K801043 (1980). 8 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K801043 | E-Vax Chest Drainage System | Cardio Surgical Concepts, Inc. | 1980 | — |
| −1 | K962856 | Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200… | Deknatel, Inc. | 1996 | 1 |
| 0 (this device) | K062302 | Millicore AB Digivent Chest Drainage System | Millicore AB | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KDQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K984496 | Atrium Medical Corporation Express Chest DrainSummary page 1…nage system Classification Name: Bottle, Collection, Vacuum 3. PREDICATE DEVICES - Express TM Chest Drainage System, Atrium Medical Corp., K984496 * Pleur-evac®, SAHARA, Deknatel DSP Worldwide Inc. (K962856) 4. DEVICE DESCRIPTION The DigiVentTM Chest Dra… | 1999 |
| * | K962856 | Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200, 2-2100…Summary page 1…Vacuum 3. PREDICATE DEVICES - Express TM Chest Drainage System, Atrium Medical Corp., K984496 * Pleur-evac®, SAHARA, Deknatel DSP Worldwide Inc. (K962856) 4. DEVICE DESCRIPTION The DigiVentTM Chest Drainage System consists primarily of a collection chamber and a… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 16.2 years on median.
- 2 of the 8 ancestors have a recall of any class.
How does its category compare?
All KDQ devicesKDQ Bottle, Collection, Vacuum: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KDQ
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · KDQ
Too few KDQ 510(k)s in any year since 2007 to give a median.
Recalls per year · KDQ
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KDQ
49in 2025
MAUDE reports naming product code KDQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 48 |
| 2008 | 1 | — | 0 | 67 |
| 2009 | 0 | — | 2 | 165 |
| 2010 | 0 | — | 1 | 50 |
| 2011 | 0 | — | 0 | 40 |
| 2012 | 0 | — | 0 | 22 |
| 2013 | 0 | — | 0 | 44 |
| 2014 | 0 | — | 2 | 43 |
| 2015 | 0 | — | 1 (1) | 34 |
| 2016 | 0 | — | 1 | 77 |
| 2017 | 0 | — | 0 | 53 |
| 2018 | 0 | — | 0 | 45 |
| 2019 | 0 | — | 1 | 57 |
| 2020 | 0 | — | 0 | 110 |
| 2021 | 0 | — | 1 | 110 |
| 2022 | 0 | — | 1 | 118 |
| 2023 | 0 | — | 1 | 92 |
| 2024 | 0 | — | 0 | 164 |
| 2025 | 0 | — | 0 | 49 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DigiVent TM Chest Drainage System is indicated to evacuate air and/or fluid from the chest cavity or mediastinum, to help prevent air and/or fluid from reaccumulating in the chest cavity or mediastinum, to help re-establish and maintain normal intrathoracic pressure gradients, and to facilitate complete lung re-expansion and restore normal breathing dynamics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062302: Millicore AB Digivent Chest Drainage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062302
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026