510(k) · Cleared
ClearedNarkomed GS 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 Mar 19, 1997 as substantially equivalent to K930351 (Draeger Medical, Inc., 1993) and 1 other predicate after a 166-day review. Its family tree reaches back 1 generation to 1993. 3 later devices descend from it.
- Decided
- Mar 19, 1997
- Review
- 166 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K930351 (1993). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK930351 Narkomed 2C Anesthesia SystemDraeger Medical, Inc. · 1993
- This deviceK963994 Narkomed GS Anesthesia SystemDraeger Medical, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK972848 Narkomed Mri Anesthesia SystemDraeger Medical, Inc. · 1997
- Descendant · 2 generations on · 0 of its ownK012446 Office Based Anesthesia Machine Mri, Model Oba-1 MriCharles A. Smith · 2001
- Descendant · cites it directly · 0 of its ownK971425 Narkomed M Anesthesia System (M)Draeger Medical, Inc. · 1997
Most influential descendants
Showing 3 of 3 · See all- K972848Narkomed Mri Anesthesia SystemDraeger Medical, Inc. · 1997 · cites it directly1descendant
- K012446Office Based Anesthesia Machine Mri, Model Oba-1 MriCharles A. Smith · 2001 · 2 generations on0descendants
- K971425Narkomed M Anesthesia System (M)Draeger Medical, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930351 | Narkomed 2C Anesthesia System | Draeger Medical, Inc. | 1993 | — |
| 0 (this device) | K963994 | Narkomed GS Anesthesia System | Draeger Medical, Inc. | 1997 | — |
| +1 | K972848 | Narkomed Mri Anesthesia System | Draeger Medical, Inc. | 1997 | — |
| +2 | K012446 | Office Based Anesthesia Machine Mri, Model Oba-1 Mri | Charles A. Smith | 2001 | — |
| +1 | K971425 | Narkomed M Anesthesia System (M) | Draeger Medical, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K930351 | Narkomed 2C Anesthesia SystemSummary page 1…Quarry Road Telford, Pennsylvania 18969 Establishment Registration Number: 2517967 Devices to which substantial equivalence is claimed: Narkomed 2C Anesthesia System K930351/A Narkomed AV2+ Anesthesia Ventilator K953228 Device Description: The NMGS is a continuous flow gas anesthesia system. Intende… | 1993 |
| * | K953228 | Narkomed AV2+ Anesthesia VentilatorSummary page 1…blishment Registration Number: 2517967 Devices to which substantial equivalence is claimed: Narkomed 2C Anesthesia System K930351/A Narkomed AV2+ Anesthesia Ventilator K953228 Device Description: The NMGS is a continuous flow gas anesthesia system. Intended Use: The NMGS may be used for spontaneous,… | 1996 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 NMGS may be used for spontaneous, manually assisted, or automatic ventilation, and delivery of gases and anesthetic vapor. The NMGS can monitor oxygen concentration, breathing pressure, and respiratory volume.
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/K963994 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963994: Narkomed GS Anesthesia System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963994
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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