510(k) · Cleared
ClearedDrager Gemina Wall-Mounted Workplace
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 30, 1996 as substantially equivalent to K921297 (Alm Surgical Equipment, Inc., 1992) after a 76-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Jul 30, 1996
- Review
- 76 days
- Class
- Class I
- Product code
- FQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K921297 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK921297 Drager Dve 4000 Series SystemAlm Surgical Equipment, Inc. · 1992
- This deviceK961886 Drager Gemina Wall-Mounted WorkplaceAlm Surgical Equipment, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921297 | Drager Dve 4000 Series System | Alm Surgical Equipment, Inc. | 1992 | — |
| 0 (this device) | K961886 | Drager Gemina Wall-Mounted Workplace | Alm Surgical Equipment, Inc. | 1996 | — |
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 10.7 · 2 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K921297 | Drager Dve 4000 Series SystemSummary page 1…age of equipment for dispensing of medical gases and electrical power. Another Drager System, the DVE 4000, a ceiling mounted system has previously been reviewed by FDA (K921297) . PRODUCT DESCRIPTION ALM Surgical Equipment Inc. will be the distributor of the Drager Gemina System in the United States. Th… | 1992 |
| * | — | Horizon Headwall System 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?
- Its one ancestor has no 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 Gemina System is a nonpowered piece of durable equipment intended to provide wall mounted physical support for medical/surgical monitoring and related equipment, storage space, and wall mounted dispensing of medical gases and electrical power required in patient care 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/K961886 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961886: Drager Gemina Wall-Mounted Workplace.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961886
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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