510(k) · Cleared
ClearedDrager Dve 8080/81/82 with Dve 4002 or Dve 4001 Series System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alm Surgical Equipment, Inc. · FQO Table, Operating-Room, Ac-Powered
Cleared on Jul 26, 1996 as substantially equivalent to K921297 (Alm Surgical Equipment, Inc., 1992) and 2 other predicates after an 81-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Jul 26, 1996
- Review
- 81 days
- Class
- Class I
- Product code
- FQO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K831086 (1983). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK831086 Ceiling Mounted SupportAmsco Co. · 1983
- This deviceK961742 Drager Dve 8080/81/82 with Dve 4002 or Dve 4001 Series SystemAlm Surgical Equipment, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K831086 | Ceiling Mounted Support | Amsco Co. | 1983 | — |
| 0 (this device) | K961742 | Drager Dve 8080/81/82 with Dve 4002 or Dve 4001 Series System | Alm Surgical Equipment, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 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 FQO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FQO device
- #1 K240598 Maestro System (REF100)score 10.8 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K921297 | Drager Dve 4000 Series SystemSummary page 1…rovide physical support, storage space, and overhead, ceiling mounted dispensing of medical gases and electrical power. The DVE 4000 has previously been reviewed by FDA (K921297). The Drager 8000/1/2 Series System and the combined DVE 8000/1/2 with DVE 4002 have been previously reviewed by FDA (K942043). T… | 1992 |
| * | K942043 | Drager Dve 8000/1/2 Series Syst W/Dve 4002 and 8032ESummary page 1…E 4000 has previously been reviewed by FDA (K921297). The Drager 8000/1/2 Series System and the combined DVE 8000/1/2 with DVE 4002 have been previously reviewed by FDA (K942043). The new DVE 8080 Series will be used in indications which are the same as indications for the DVE 4000, DVE 8000, DVE 8032E and… | 1994 |
| * | K831086 | Ceiling Mounted SupportSummary page 5…ital grade electrical receptacles. Fully Rotational, Fully Articulated Height Adjustable Variable Lengths, 24 to 34 inches 3 Combinable Lengths Premarket Notification K831086 Any Manufacturer, Including Chemetron, Puritan Bennett, Ohio Med. Prod., Oxyquip. 28 inches | 1983 |
| * | — | Heraeus Hanauport 810 Universal Ceiling Column Named without a submission number |
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?
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K921297.
How does its category compare?
All FQO devicesFQO Table, Operating-Room, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FQO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FQO
Too few FQO 510(k)s in any year since 2007 to give a median.
Recalls per year · FQO
8in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FQO
113in 2025
MAUDE reports naming product code FQO, 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 | 61 |
| 2008 | 0 | — | 10 | 47 |
| 2009 | 1 | — | 3 | 58 |
| 2010 | 0 | — | 3 | 127 |
| 2011 | 0 | — | 7 | 101 |
| 2012 | 0 | — | 0 | 120 |
| 2013 | 0 | — | 1 | 116 |
| 2014 | 0 | — | 1 | 145 |
| 2015 | 0 | — | 2 | 108 |
| 2016 | 0 | — | 2 | 93 |
| 2017 | 0 | — | 0 | 98 |
| 2018 | 0 | — | 5 | 104 |
| 2019 | 0 | — | 0 | 118 |
| 2020 | 0 | — | 2 | 97 |
| 2021 | 0 | — | 0 | 102 |
| 2022 | 1 | — | 1 | 125 |
| 2023 | 0 | — | 2 | 187 |
| 2024 | 1 | — | 8 | 139 |
| 2025 | 0 | — | 0 | 113 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Drager DVE 8080 System is a piece of durable equipment intended to provide ceiling mounted overhead physical support for anaesthesia machines, medical/surgical monitoring and related equipment, storage space, and ceiling mounted dispensing of medical gases and electrical power required in clinical settings, emergency rooms, intensive care, procedure rooms and operating rooms.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961742 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961742: Drager Dve 8080/81/82 with Dve 4002 or Dve 4001 Series System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961742
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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