510(k) · Cleared
ClearedBEACON Caresystem Model 00002144
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mermaid Care A/S · BZK Spirometer, Monitoring (W/Wo Alarm)
Cleared on Dec 18, 2019 as substantially equivalent to K103578 (Respironics Novametrix, LLC, 2011) after a 90-day review. Its family tree reaches back 9 generations to 1991. 4 of the 42 devices in its family, counting itself, have a Class I recall.
- Decided
- Dec 18, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- BZK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K902859 (1991). 41 ancestors in all, the oldest K900696 (1990). No later device cites it as a predicate yet. 4 of the 42 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 5 generations between
- 3 generations backK051263 Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · Recalled
- 2 generations backK053388 Model 840 Ventilator with Proportional Assist Ventilation Plus…Puritan Bennett Corp. · 2006 · Recalled (Class I)
- 1 generation backK103578 Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC · 2011
- This deviceK192584 BEACON Caresystem Model 00002144Mermaid Care A/S · 2019
Show all 9 generations
- Root · 9 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 8 generations backK961687 EVITA 4Drager, Inc. · 1996
- 7 generations backK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- 6 generations backK984535 Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · Recalled (Class I)
- 5 generations backK022679 RaphaelHamilton Medical AG · 2003 · Recalled
- 4 generations backK040574 Galileo GoldHamilton Medical, Inc. · 2004
- 3 generations backK051263 Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · Recalled
- 2 generations backK053388 Model 840 Ventilator with Proportional Assist Ventilation Plus…Puritan Bennett Corp. · 2006 · Recalled (Class I)
- 1 generation backK103578 Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC · 2011
- This deviceK192584 BEACON Caresystem Model 00002144Mermaid Care A/S · 2019
Class I recalls in this family
- K053388 Model 840 Ventilator with Proportional Assist…2 generations back · 2006
- K001646 Puritan-Bennett 840 Ventilator System with…4 generations back · 2000
- K984535 Puritan-Bennett 840 Ventilatory System with…4 generations back · 1998
- K970460 Nellcor Puritan Bennett, 840 Ventilator System…5 generations back · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −8 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −7 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| −6 | K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel Option | Puritan Bennett Corp. | 1998 | Class I |
| −5 | K022679 | Raphael | Hamilton Medical AG | 2003 | 3 |
| −4 | K040574 | Galileo Gold | Hamilton Medical, Inc. | 2004 | — |
| −3 | K051263 | Evitaxl with Option Smartcare | Drager Medical AG & Co. Kgaa | 2005 | 1 |
| −2 | K053388 | Model 840 Ventilator with Proportional Assist Ventilation Plus Software Option | Puritan Bennett Corp. | 2006 | Class I |
| −1 | K103578 | Philips NM3 Respiratory Monitor with Ventassist | Respironics Novametrix, LLC | 2011 | — |
| 0 (this device) | K192584 | BEACON Caresystem Model 00002144 | Mermaid Care A/S | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 1 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2009 | 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.
4 devices in this family have a Class I recall. 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 BZK device
- #1 K260226 ElintMAX Respiratory Monitor (ElintMAX Monitor…score 19.5 · 26 generations · no Class I recall
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K103578 | Philips NM3 Respiratory Monitor with VentassistSummary page 4…Spirometer, Monitoring (W/Wo Alarm) [21 C.F.R. §868.1850] Class: II Predicate Device: Philips NM3 Respiratory Monitor with VentAssist (K103578) Reference Device and GE Healthcare Datex-Ohmeda S/5TM Compact Airway Module (model accessories: family… | 2011 |
| † | K051092 | Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx, E-Caiov… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp. · 2006 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 4 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 28 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
- 17 of the 41 ancestors have a recall of any class; 4 have a Class I recall.
- 1 other device also cites its predicate K103578.
How does its category compare?
All BZK devicesBZK Spirometer, Monitoring (W/Wo Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · BZK
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · BZK
71in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZK
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZK
2in 2020
MAUDE reports naming product code BZK, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 71 | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 2 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 73 |
| 2014 | 0 | — | 0 | 31 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The intended use of the BEACON Caresystem is to provide
• respiratory mechanics monitoring in adult patients in the Intensive Care Unit (ICU)
• on-demand ventilator-dependent open-loop advice in mechanically ventilated adult patients as prescribed by the clinician
Patients should be hemodynamically stable.
The device is intended for use by properly trained clinicians. BEACON Caresystem is for prescription use, only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192584 · printed Nov 3, 2026
Cite this page
510(k) Report. “K192584: BEACON Caresystem Model 00002144.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K192584
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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