510(k) · Cleared
ClearedStartrack Infant Graphics Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nellcor Puritan Bennett, Inc. · BZK Spirometer, Monitoring (W/Wo Alarm)
Cleared on Dec 9, 1998 as substantially equivalent to K890724 (Bear Medical Systems, Inc., 1989) after an 83-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.
- Decided
- Dec 9, 1998
- Review
- 83 days
- Class
- Class II
- Product code
- BZK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K890724 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK890724 Mofification Bear NVM-1 Neonatal Volume MonitorBear Medical Systems, Inc. · 1989
- This deviceK983274 Startrack Infant Graphics MonitorNellcor Puritan Bennett, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK051279 Caldyne, Inc. Exhalometer EX100, Model EX100Caldyne, Inc. · 2005
Most influential descendants
Showing 1 of 1 · See all- K051279Caldyne, Inc. Exhalometer EX100, Model EX100Caldyne, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890724 | Mofification Bear NVM-1 Neonatal Volume Monitor | Bear Medical Systems, Inc. | 1989 | — |
| 0 (this device) | K983274 | Startrack Infant Graphics Monitor | Nellcor Puritan Bennett, Inc. | 1998 | — |
| +1 | K051279 | Caldyne, Inc. Exhalometer EX100, Model EX100 | Caldyne, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 BZK? 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 |
|---|---|---|---|
| * | K890724 | Mofification Bear NVM-1 Neonatal Volume MonitorSummary page 1…nducted as well as in-vitro testing to confirm the accuracy of StarTrack. The predicate device is as follows: Bear Medical Systems Neonatal Volume Monitor, model NVM-1, K890724. Section 16.e Device Description The StarTrack Infant Graphics Monitor, StarTrack is contained in a rectangular metal enclosure… | 1989 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051279 | Caldyne, Inc. Exhalometer EX100, Model EX100 | 2005 | 0 |
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.
- Of its descendants, K051279 (Caldyne, Inc., 2005) has gone furthest, with 0 descendants of its own.
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.
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 StarTrack Infant Graphics Monitor’s intended use is the measurement and display of breathing flow, volume and pressure as delivered trough the patient's endotracheal tube. The intended patient population comprises neonatal and pediatric patients requiring an endotracheal tube <5.0mm I.D. and/or who do not exceed a peak breathing flow of 30 L/Min directly through the ET tube. The intended environments of use comprise Hospital, Hospital-type and…
Read the full statement (128 words)
The StarTrack Infant Graphics Monitor’s intended use is the measurement and display of breathing flow, volume and pressure as delivered trough the patient's endotracheal tube. The intended patient population comprises neonatal and pediatric patients requiring an endotracheal tube <5.0mm I.D. and/or who do not exceed a peak breathing flow of 30 L/Min directly through the ET tube. The intended environments of use comprise Hospital, Hospital-type and Intra-Hospital Transport environments. The device is for prescription use only. Hospital use typically covers such areas as general care floors, operating rooms, special procedure areas, intensive and critical care areas, within the hospital plus hospital-type facilities such as Surgicenters, Sub-acute Centers and Special Nursing Facilities, outside of the hospital. Intra-hospital transport includes transport with a patient within the hospital or hospital-type facility.
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/K983274 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983274: Startrack Infant Graphics Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983274
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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