510(k) · Cleared
ClearedOffice Based Anesthesia Machine Mri, Model Oba-1 Mri
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Charles A. Smith · BSZ Gas-Machine, Anesthesia
Cleared on Oct 3, 2001 as substantially equivalent to K000859 (Charles A. Smith, 2000) and 1 other predicate after a 63-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Oct 3, 2001
- Review
- 63 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K930351 (1993). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK930351 Narkomed 2C Anesthesia SystemDraeger Medical, Inc. · 1993
- 2 generations backK963994 Narkomed GS Anesthesia SystemDraeger Medical, Inc. · 1997
- 1 generation backK972848 Narkomed Mri Anesthesia SystemDraeger Medical, Inc. · 1997
- This deviceK012446 Office Based Anesthesia Machine Mri, Model Oba-1 MriCharles A. Smith · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930351 | Narkomed 2C Anesthesia System | Draeger Medical, Inc. | 1993 | — |
| −2 | K963994 | Narkomed GS Anesthesia System | Draeger Medical, Inc. | 1997 | — |
| −1 | K972848 | Narkomed Mri Anesthesia System | Draeger Medical, Inc. | 1997 | — |
| 0 (this device) | K012446 | Office Based Anesthesia Machine Mri, Model Oba-1 Mri | Charles A. Smith | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K000859 | Office Based Anesthesia Machine, Model Oba-1Summary page 1…OBA-1™ MRI - Office Based Anesthesia Unit MRI Common/Usual Name: Anesthesia gas machine Classification Name: Gas machine, anesthesia Predicate Devices: Smith - OBA-1™ - K000859 Drager - Narkomed MRI Anesthesia System K972848 The OBA-1™ MRI is an anesthesia unit which includes these features: Can be con… | 2000 |
| * | K972848 | Narkomed Mri Anesthesia SystemSummary page 1…mmon/Usual Name: Anesthesia gas machine Classification Name: Gas machine, anesthesia Predicate Devices: Smith - OBA-1™ - K000859 Drager - Narkomed MRI Anesthesia System K972848 The OBA-1™ MRI is an anesthesia unit which includes these features: Can be connected to a central pipeline or cylinder oxygen/a… | 1997 |
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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K000859.
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 Office Based Anesthesia Unit - OBA-1™ MRI is intended for
administration of general inhalation anesthesia using mixtures of
oxygen, air and volatile anesthetics, and for providing breathing gas
and for either spontaneous ventilation or controlled ventilation of
patient lungs.
The OBA-1™ MRI can be used in MRI scanner rooms with
shielded or unshielded magnets up to 1.5 tesla.
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/K012446 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012446: Office Based Anesthesia Machine Mri, Model Oba-1 Mri.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012446
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026