510(k) · Cleared
ClearedOhmeda Apac (Advanced Portable Anesthesia Care) 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 Jun 17, 1997 after a 182-day review. The FDA summary names its predicate without a number.
- Decided
- Jun 17, 1997
- Review
- 182 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (1)
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 |
|---|---|---|---|
| * | — | Ohmeda Excel Series Anesthesia Machines 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.
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 APAC is a self-contained, portable and lightweight anesthesia machine that includes the components and accessories necessary to deliver anesthesia. Gases and vaporizers The APAC System delivers three breathing circuit gases: O₂ (cylinder or pipeline) N₂O (pipeline only) air (pipeline only) The APAC System includes a Tec 5 Vaporizer Ventilators The APAC System uses a 7800 Ventilator changed to use O₂ or air as the pneumatic power source. Patient…
Read the full statement (173 words)
The APAC is a self-contained, portable and lightweight anesthesia machine that includes the components and accessories necessary to deliver anesthesia.
Gases and vaporizers
The APAC System delivers three breathing circuit gases:
O₂ (cylinder or pipeline)
N₂O (pipeline only)
air (pipeline only)
The APAC System includes a Tec 5 Vaporizer
Ventilators
The APAC System uses a 7800 Ventilator changed to use O₂ or air as the pneumatic power source.
Patient Safety
Safety devices decrease the risk of:
Hypoxic Mixtures
A flow control proportioning system keeps the O₂ concentration higher than 23% at the fresh gas outlet for O₂ and N₂O mixtures.
N₂O flow decreases proportionally as the O₂ supply decreases.
N₂O and air flow stops completely in case of total O₂ supply failure.
Complete power or sudden gas supply failures
Batteries continue 7800 Ventilator operation during a power failure.
Ohmeda ventilators have power failure alarms.
Ohmeda ventilators have alarms for low gas supply pressure.
The APAC System has an alarm for O₂ supply pressures less than 27 to 33 psig (186 to 228 kPa).
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/K965041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K965041: Ohmeda Apac (Advanced Portable Anesthesia Care) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K965041
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026