510(k) Report

510(k) · Cleared

Cleared

Magellan-2200 Model -2 Anesthesia Machine, Model 2

K060193510(k) TraditionalCleared Apr 10, 200675-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

Oceanic Medical Products, Inc. · BSZ Gas-Machine, Anesthesia

Cleared on Apr 10, 2006 as substantially equivalent to K010613 (Oceanic Medical Products, Inc., 2001) after a 75-day review. Its family tree reaches back 1 generation to 2001.

Decided
Apr 10, 2006
Review
75 days
Class
Class II
Product code
BSZ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K010613 (2001). No later device cites it as a predicate yet.

K010613 · Magellan-2200, Model 1 · Oceanic Medical Products, Inc. · 200120002002200420062008
K010613 · Magellan-2200, Model 1 · Oceanic Medical Products, Inc. · 20010
  1. Root · 1 generation backK010613 Magellan-2200, Model 1Oceanic Medical Products, Inc. · 2001
  2. This deviceK060193 Magellan-2200 Model -2 Anesthesia Machine, Model 2Oceanic Medical Products, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K010613Magellan-2200, Model 1Oceanic Medical Products, Inc.2001—
0 (this device)K060193Magellan-2200 Model -2 Anesthesia Machine, Model 2Oceanic Medical Products, Inc.2006—
FIG. 1 — Lineage of K060193, 2001–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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. #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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K010613Magellan-2200, Model 1
Summary page 1
…ine, Anesthesia C.F.R. Section: 21 C.F.R. § 868.6160 Product Code : BSZ Predicate Device: Magellan-2200 Model-I Anesthesia Machine (K010613) Manufacturer: Oceanic Medical Products, Inc. Intended Use: The Magellan-2200 Model-2 Anesthesia Ma…
Oceanic Medical Products, Inc.2001—

Also cleared against K010613: 1 other device →

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?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate K010613.

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)—

What is it indicated for?

The Magellan-2200 Model-2 Anesthesia Machine is Intended for spontaneous, manually assisted or automatic ventilation of patients during anesthesia. It may be used for the delivery of gases and anesthetic vapor. It is capable of monitor/alarm functions for oxygen concentration, breathing pressure and respiratory volumes.

The Magellan-2200 Model-2 Anesthesia Machine in indicated for use with spontaneous, manually assisted or automatic ventilation of patients during anesthesia. It may be used for the delivery of gases and anesthetic vapor. It is capable of monitor/alarm functions for oxygen concentration, breathing pressure and respiratory volumes.

Indications for use as stated in the FDA summary.

Also cleared against K010613

1 other device cites the same predicate.

  • K072420Magellan-2200, Model-3 Anesthesia MachineOceanic Medical Products, Inc. · 2008

More from Oceanic Medical Products, Inc.

4 FDA decisions under this applicant name. See the company

  • K072420Magellan-2200, Model-3 Anesthesia MachineOceanic Medical Products, Inc. · 2008
  • K010613Magellan-2200, Model 1Oceanic Medical Products, Inc. · 2001
  • K002951Magellan VentilatorOceanic Medical Products, Inc. · 2000

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/K060193 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060193: Magellan-2200 Model -2 Anesthesia Machine, Model 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060193

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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