510(k) · Cleared
ClearedOhmeda Excel Draw-Over Military Vaporizer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ohmeda Medical · BSZ Gas-Machine, Anesthesia
Cleared on Oct 8, 1996 as substantially equivalent to K863207 (Ohmeda Medical, 1986) and 1 other predicate after a 663-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Oct 8, 1996
- Review
- 663 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K850648 (1985). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK850648 Ohmeda Pac Portable Anesthesia SystemOhmeda Medical · 1985
- This deviceK946127 Ohmeda Excel Draw-Over Military Vaporizer SystemOhmeda Medical · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K850648 | Ohmeda Pac Portable Anesthesia System | Ohmeda Medical | 1985 | — |
| 0 (this device) | K946127 | Ohmeda Excel Draw-Over Military Vaporizer System | Ohmeda Medical | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K863207 | Ohmeda 'B' Series Gas Delivery SystemSummary page 1…Delivery System (currently known as the Ohmeda Excel Anesthesia System) which was the subject of a cleared 510(k) premarket notification on 10/30/86 with FDA log number K863207. 2. Ohmeda PAC Portable Anesthesia Machine that was the subject of a cleared §10(k) premarket notification . on 7/1/85 with FDA… | 1986 |
| * | K850648 | Ohmeda Pac Portable Anesthesia System Our OCR of the scanned summary read K850848, FDA’s number for Brain Heart Infusion Agar (Micro Media Laboratories). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Ohmeda PAC Portable Anesthesia Machine”. | 1985 |
| Kept off the family tree | K901117 | FDA’s K901117 is Ohmeda Universal Pac Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1990 |
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 2 ancestors has a recall.
How does its category compare?
All BSZ devicesBSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 purpose is to provide a platform for the delivery of inhalation anesthetic agents using the draw-over vaporizer and supplemental gas supply.
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/K946127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K946127: Ohmeda Excel Draw-Over Military Vaporizer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K946127
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