510(k) · Cleared
ClearedNarkomed Mri Anesthesia System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical, Inc. · BSZ Gas-Machine, Anesthesia
Cleared on Oct 30, 1997 as substantially equivalent to K963994 (Draeger Medical, Inc., 1997) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Oct 30, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K930351 (1993). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK930351 Narkomed 2C Anesthesia SystemDraeger Medical, Inc. · 1993
- 1 generation backK963994 Narkomed GS Anesthesia SystemDraeger Medical, Inc. · 1997
- This deviceK972848 Narkomed Mri Anesthesia SystemDraeger Medical, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK012446 Office Based Anesthesia Machine Mri, Model Oba-1 MriCharles A. Smith · 2001
Most influential descendants
Showing 1 of 1 · See all- K012446Office Based Anesthesia Machine Mri, Model Oba-1 MriCharles A. Smith · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930351 | Narkomed 2C Anesthesia System | Draeger Medical, Inc. | 1993 | — |
| −1 | K963994 | Narkomed GS Anesthesia System | Draeger Medical, Inc. | 1997 | — |
| 0 (this device) | K972848 | Narkomed Mri Anesthesia System | Draeger Medical, Inc. | 1997 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K963994 | Narkomed GS Anesthesia SystemSummary page 1…5 Quarry Road Telford, Pennsylvania 18969 Establishment Registration Number: 2517967 Devices to which substantial equivalence is claimed: Narkomed GS Anesthesia System K963994 Core-M Omicron Monitor K960861 Device Description: The NM-MRI is a continuous flow gas anesthesia system. Intended Use: The N… | 1997 |
| * | K960861 | Omicron Monitor, Delta MonitorSummary page 1…ania 18969 Establishment Registration Number: 2517967 Devices to which substantial equivalence is claimed: Narkomed GS Anesthesia System K963994 Core-M Omicron Monitor K960861 Device Description: The NM-MRI is a continuous flow gas anesthesia system. Intended Use: The NM-MRI can be used for spontaneo… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012446 | Office Based Anesthesia Machine Mri, Model Oba-1 Mri | 2001 | 0 |
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 4 years and passes through 1 company; a new generation was cleared every 3.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K012446 (Charles A. Smith, 2001) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K963994.
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 NM-MRI is a continuous flow anesthesia system. The NM-MRI may be used for spontaneous, manually assisted, or automatic ventilation, and delivery of gases, anesthetic vapor, and monitoring of oxygen concentration, breathing pressure, and respiratory volume. The NM-MRI is indicated for use with the Driger Vapor® 19.1. The NM- MRI may be used in MRI scanner rooms with magnets up to 1.5 tesla, and with magnets over 1.5 tesla when installed using the NM-MRI High field Mounting Kit. Federal law restricts this device to sale by, or on the order of, a physician.
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/K972848 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972848: Narkomed Mri Anesthesia System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972848
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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