510(k) · Cleared
Recalled · Class II · 2018Fourth Gas Module with CO2 for Primus US Apollo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical AG & Co. KG · BSZ Gas-Machine, Anesthesia
Cleared on Oct 8, 2008 as substantially equivalent to K000706 (Datex-Ohmeda, Inc., 2000) and 1 other predicate after a 139-day review. Its family tree reaches back 1 generation to 1998. It has been recalled once.
- Decided
- Oct 8, 2008
- Review
- 139 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K973896 (1998). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK973896 Ohmeda Excel 3000 Anesthesia SystemOhmeda Medical · 1998 · Recalled
- This deviceK081447 Fourth Gas Module with CO2 for Primus US ApolloDraeger Medical AG & Co. KG · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973896 | Ohmeda Excel 3000 Anesthesia System | Ohmeda Medical | 1998 | 1 |
| 0 (this device) | K081447 | Fourth Gas Module with CO2 for Primus US Apollo | Draeger Medical AG & Co. KG | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 BSZ? 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 BSZ device
- #1 K253330 A5 Anesthesia System (A5); A7 Anesthesia…score 16.7 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K000706 | Datex-Ohmeda Aestiva/5 with 7100 VentilatorSummary page 2…the following devices: DEVICE 510(k) NUMBER Aestiva/5 Anesthesia System K000706 Ohmeda Excel 3000 Anesthesia System K973896 The Fourth Gas Module with C02 for Primus US "Apollo"… | 2000 |
| * | K973896 | Ohmeda Excel 3000 Anesthesia SystemSummary page 2…510(k) NUMBER Aestiva/5 Anesthesia System K000706 Ohmeda Excel 3000 Anesthesia System K973896 The Fourth Gas Module with C02 for Primus US "Apollo" provides, as does the Aestive/5 or the Excel 3000, a mechanical means of… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 24, 2018 | Class II | Z-2253-2018 | Process change control | The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 2 of the 2 ancestors have a recall of any class.
- 3 other devices also cite its predicate K000706.
How does its category compare?
All BSZ devicesBSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · BSZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSZ
145in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSZ
5in 2025
Class I (38 since 2007) Class II/III not classified
Adverse event reports per year · BSZ
9,198in 2025
MAUDE reports naming product code BSZ, 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 | 3 | 175 | 1 | 132 |
| 2008 | 8 | 99 | 8 | 104 |
| 2009 | 3 | 34 | 3 | 85 |
| 2010 | 1 | — | 14 | 97 |
| 2011 | 6 | 218 | 1 | 87 |
| 2012 | 5 | 134 | 7 (6) | 89 |
| 2013 | 5 | 125 | 5 (5) | 308 |
| 2014 | 4 | 235 | 0 | 279 |
| 2015 | 4 | 134 | 7 (2) | 572 |
| 2016 | 1 | — | 1 | 2,135 |
| 2017 | 3 | 145 | 5 (1) | 2,355 |
| 2018 | 2 | — | 3 | 2,589 |
| 2019 | 0 | — | 5 (2) | 1,957 |
| 2020 | 1 | — | 7 | 2,687 |
| 2021 | 1 | — | 2 (1) | 3,123 |
| 2022 | 0 | — | 4 (3) | 4,352 |
| 2023 | 2 | — | 6 | 5,595 |
| 2024 | 0 | — | 13 (13) | 6,067 |
| 2025 | 1 | — | 5 (3) | 9,198 |
| 2026 | 2 | — | 7 (2) | — |
What is it indicated for?
The Primus US "Apollo" is indicated as a continuous flow anesthesia system. The Primus US "Apollo" may be used for manually assisted, or automatic ventilation, and delivery of gases (02, N 2 0 and CO 2 - in combination with the CO 2 module [i.e. Fourth Gas Module]), anesthetic vapor, and monitoring of oxygen and CO 2 concentrations, breathing pressure, respiratory volume, and anesthetic agent identification and concentration. Federal law restricts this device to sale by or on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081447 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081447: Fourth Gas Module with CO2 for Primus US Apollo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081447
Report an extraction error
Are you the manufacturer?
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