510(k) · Cleared
Recalled · 2006Cosmo Plus with Nico, Model 8200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novametrix Medical Systems, Inc. · BZC Calculator, Pulmonary Function Data
Cleared on Oct 16, 1998 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 252 devices in its family, counting itself, has a Class I recall. 251 later devices descend from it. It has been recalled once.
- Decided
- Oct 16, 1998
- Review
- 88 days
- Class
- Class II
- Product code
- BZC
- Recalls
- 1
- Predicates
- 0
251 later devices descend from it, 3 citing it directly. 1 of the 252 devices in this family, counting this one, has a Class I recall.
- This deviceK982499 Cosmo Plus with Nico, Model 8200Novametrix Medical Systems, Inc. · 1998
- Descendant · cites it directly · 246 of its ownK030886 Nico with Mars, Model 7300Respironics Novametrix, Inc. · 2003 · Recalled
- Descendant · cites it directly · 233 of its ownK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
- Descendant · 2 generations on · 222 of its ownK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- Descendant · 2 generations on · 221 of its ownK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
- Descendant · 2 generations on · 211 of its ownK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
Showing 5 of 251 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073069 Modification to Avea Ventilatorcites it directly · 2008
Most influential descendants
Showing 5 of 251 · See all- K030886Nico with Mars, Model 7300Respironics Novametrix, Inc. · 2003 · cites it directly246descendants
- K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00Philips Medizin Systeme Boeblingen GmbH · 2006 · cites it directly233descendants
- K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006 · 2 generations on222descendants
- K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH · 2006 · 2 generations on221descendants
- K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc. · 2006 · 2 generations on211descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982499 | Cosmo Plus with Nico, Model 8200 | Novametrix Medical Systems, Inc. | 1998 | — |
| +1 | K030886 | Nico with Mars, Model 7300 | Respironics Novametrix, Inc. | 2003 | 8 |
| +1 | K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| +2 | K060221 | The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| +2 | K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient… | Philips Medizin Systeme Boblingen GmbH | 2006 | 2 |
| +2 | K061052 | The Philips Intellivue Patient Monitors, Models… | Philips Medical Systems North America, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 9 | 0 |
| 2007 | 3 | 0 |
| 2008 | 7 | 1 |
| 2009 | 7 | 0 |
| 2010 | 8 | 0 |
| 2011 | 10 | 0 |
| 2012 | 9 | 0 |
| 2013 | 12 | 0 |
| 2014 | 10 | 0 |
| 2015 | 7 | 0 |
| 2016 | 11 | 0 |
| 2017 | 12 | 0 |
| 2018 | 14 | 0 |
| 2019 | 11 | 0 |
| 2020 | 9 | 0 |
| 2021 | 14 | 0 |
| 2022 | 18 | 0 |
| 2023 | 22 | 0 |
| 2024 | 18 | 0 |
| 2025 | 23 | 0 |
| 2026 | 13 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has 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 BZC device
- #1 K240293 STSscore 9.8 · 7 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (251)
See all 2513 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 11, 2006 | Not classified | Z-1535-06 | Other | Audible alarm may not sound during an alert condition |
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.
- K073069Modification to Avea VentilatorViasys Respiratory Care, Inc. · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 113 Class I recalls
What does this lineage say?
- Of its descendants, K030886 (Respironics Novametrix, Inc., 2003) has gone furthest, with 246 descendants of its own.
How does its category compare?
All BZC devicesBZC Calculator, Pulmonary Function Data: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BZC
Too few BZC 510(k)s in any year since 2007 to give a median.
Recalls per year · BZC
3in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZC
3in 2025
MAUDE reports naming product code BZC, 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 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 3 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The intended use of the CO,SMO Plus! with NICO is to provide: • cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the intensive care unit (ICU). • spirometric, carbon dioxide and pulse oximetry monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) 4nd the emergency department (ED). Separate flow…
Read the full statement (283 words)
The intended use of the CO,SMO Plus! with NICO is to provide:
• cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the intensive care unit (ICU).
• spirometric, carbon dioxide and pulse oximetry monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) 4nd the emergency department (ED). Separate flow sensors and CO, airway adapters are provided for pediatric/adult and neonatal use.
It is intended to be used by trained operators when spirometric, capnographic, pulse oximetry, or cardiac output monitoring is indicated in the judgement of a physician.
Itis intended that:
= the neonatal flow and combined CO,/flow sensors be used with ET tube sizes less than or equal to 4 mm and
» the pediatric/adult flow and combined CO,/flow sensors be used with ET tube sizes greater than 4 mm or with 22 mm ID breathing circuit devices such as a mouthpiece.
The fittings of the flow sensors and CO, airway adapters comply with ISO [5356-1: 1987 (E)].
The flow sensors and CO, airway adapters may be used in conjunction with endotracheal tubes, face masks, and breathing circuit devices that also comply with the same fitting specification.
The flow sensors, combination CO /flow sensors, single patient use CO, airway adapters and valve assembly are single patient use devices.
The CO,SMO Plus! with NICO can calculate additional parameters such as cardiac output, pulmonary capillary blood flow, cardiac index, stroke volume and systemic vascular resistance.
The use of the CO,SMO Plus! with NICO is contraindicated in patients in which a smali rise (3-5 mmHg) in their arterial partial pressure of CO, level cannot be tolerated.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982499 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982499: Cosmo Plus with Nico, Model 8200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982499
Report an extraction error
Are you the manufacturer?
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