510(k) Report

510(k) · Cleared

Cleared

Narkomed 2C Anesthesia System

K930351510(k) TraditionalCleared Jun 22, 1993148-day reviewClass II21 CFR 868.5160

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Draeger Medical, Inc. · BSZ Gas-Machine, Anesthesia

Cleared on Jun 22, 1993 after a 148-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.

Decided
Jun 22, 1993
Review
148 days
Class
Class II
Product code
BSZ
Recalls
None
Predicates
0

5 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1997: 4 descendants cleared2001: 1 descendant cleared1990200020102020
  1. This deviceK930351 Narkomed 2C Anesthesia SystemDraeger Medical, Inc. · 1993
  2. Descendant · cites it directly · 3 of its ownK963994 Narkomed GS Anesthesia SystemDraeger Medical, Inc. · 1997
  3. Descendant · 2 generations on · 1 of its ownK972848 Narkomed Mri Anesthesia SystemDraeger Medical, Inc. · 1997
  4. Descendant · 3 generations on · 0 of its ownK012446 Office Based Anesthesia Machine Mri, Model Oba-1 MriCharles A. Smith · 2001
  5. Descendant · 2 generations on · 0 of its ownK971425 Narkomed M Anesthesia System (M)Draeger Medical, Inc. · 1997
  6. Descendant · cites it directly · 0 of its ownK963481 Anodyne CCHeyer America, Inc. · 1997

Most influential descendants

Showing 5 of 5 · See all
  • K963994Narkomed GS Anesthesia SystemDraeger Medical, Inc. · 1997 · cites it directly3descendants
  • K972848Narkomed Mri Anesthesia SystemDraeger Medical, Inc. · 1997 · 2 generations on1descendant
  • K012446Office Based Anesthesia Machine Mri, Model Oba-1 MriCharles A. Smith · 2001 · 3 generations on0descendants
  • K971425Narkomed M Anesthesia System (M)Draeger Medical, Inc. · 1997 · 2 generations on0descendants
  • K963481Anodyne CCHeyer America, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K930351Narkomed 2C Anesthesia SystemDraeger Medical, Inc.1993—
+1K963994Narkomed GS Anesthesia SystemDraeger Medical, Inc.1997—
+2K972848Narkomed Mri Anesthesia SystemDraeger Medical, Inc.1997—
+3K012446Office Based Anesthesia Machine Mri, Model Oba-1 MriCharles A. Smith2001—
+2K971425Narkomed M Anesthesia System (M)Draeger Medical, Inc.1997—
+1K963481Anodyne CCHeyer America, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199740
200110
FIG. 1 — Lineage of K930351, 1993–2001Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K253330 A5 Anesthesia System (A5); A7 Anesthesia…score 16.7 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (5)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K963994Narkomed GS Anesthesia SystemDraeger Medical, Inc.19973
K963481Anodyne CCHeyer America, Inc.19970

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?

  • Of its descendants, K963994 (Draeger Medical, Inc., 1997) has gone furthest, with 3 descendants of its own.

How does its category compare?

All BSZ devices

BSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BSZ

1in 2025

2007: 32008: 82009: 32010: 12011: 62012: 52013: 52014: 42015: 42016: 12017: 32018: 22020: 12021: 12023: 22025: 12026 (partial year): 2
2007high 8 (2008) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BSZ

145in 2017

2007: 175 days median2008: 99 days median2009: 34 days median2011: 218 days median2012: 134 days median2013: 125 days median2014: 235 days median2015: 134 days median2017: 145 days median
2007high 235 (2014) · low 34 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BSZ

5in 2025

2007: 12008: 82009: 32010: 142011: 12012: 7, 6 Class I2013: 5, 5 Class I2015: 7, 2 Class I2016: 12017: 5, 1 Class I2018: 32019: 5, 2 Class I2020: 72021: 2, 1 Class I2022: 4, 3 Class I2023: 62024: 13, 13 Class I2025: 5, 3 Class I2026 (partial year): 7, 2 Class I
2007high 14 (2010) · low 0 (2014)2026

Class I (38 since 2007) Class II/III not classified

Adverse event reports per year · BSZ

9,198in 2025

2007: 1322008: 1042009: 852010: 972011: 872012: 892013: 3082014: 2792015: 5722016: 2,1352017: 2,3552018: 2,5892019: 1,9572020: 2,6872021: 3,1232022: 4,3522023: 5,5952024: 6,0672025: 9,198
2007high 9,198 (2025) · low 85 (2009)2025

MAUDE reports naming product code BSZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200731751132
20088998104
2009334385
20101—1497
20116218187
201251347 (6)89
201351255 (5)308
201442350279
201541347 (2)572
20161—12,135
201731455 (1)2,355
20182—32,589
20190—5 (2)1,957
20201—72,687
20211—2 (1)3,123
20220—4 (3)4,352
20232—65,595
20240—13 (13)6,067
20251—5 (3)9,198
20262—7 (2)—

More from Draeger Medical, Inc.

78 FDA decisions under this applicant name. See the company

  • K042607Primus USDraeger Medical, Inc. · 20042 recalls
  • K042419Fabius GS/Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 20044 Class I recalls
  • K042276D-VaporDraeger Medical, Inc. · 20041 recall
  • K042086Fabius GS Anesthesia System; Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2004
  • K041622Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2004

Recent decisions in BSZ

The BSZ category page

  • K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
  • K252746Atlan (A100); Atlan (A100 XL); Atlan (A350); Atlan (A350 XL)Drägerwerk AG Co. Kgaa · 2026
  • K251352Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series…Codonics.Incorporated · 2025
  • K230931AtlanDrägerwerk AG Co. Kgaa · 20238 Class I recalls
  • K213867Carestation 750/750cDatex-Ohmeda, Inc. · 20234 Class I recalls

https://510kreport.com/device/K930351 · printed Nov 6, 2026

Cite this page

510(k) Report. “K930351: Narkomed 2C Anesthesia System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930351

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026