510(k) · Cleared
ClearedCaldyne, Inc. Exhalometer EX100, Model EX100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caldyne, Inc. · BZK Spirometer, Monitoring (W/Wo Alarm)
Cleared on Sep 7, 2005 as substantially equivalent to K983274 (Nellcor Puritan Bennett, Inc., 1998) and 1 other predicate after a 113-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Sep 7, 2005
- Review
- 113 days
- Class
- Class II
- Product code
- BZK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K914272 (1992). 4 ancestors in all, the oldest K890724 (1989). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914272 | Koko Spirometer | Ferraris Respiratory, Inc. | 1992 | — |
| −1 | K973314 | Spirosafe Filter | Micro Direct, Inc. | 1997 | — |
| 0 (this device) | K051279 | Caldyne, Inc. Exhalometer EX100, Model EX100 | Caldyne, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1998 | 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? (2)
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 |
|---|---|---|---|
| * | K983274 | Startrack Infant Graphics MonitorSummary page 5…n establishes the substantial equivalence of the CALDYNE, Inc. EXHALOMETER Tm EX100 to two predicate devices: (1) The Star-Track Infant Graphics Monitor, K983274, SE letter: 12/09/98. (2) The Newport Compass Exhaled Tidal Volume Monitor, K973314, SE letter: 10125/93.… | 1998 |
| * | K973314 | Spirosafe FilterSummary page 5…two predicate devices: (1) The Star-Track Infant Graphics Monitor, K983274, SE letter: 12/09/98. (2) The Newport Compass Exhaled Tidal Volume Monitor, K973314, SE letter: 10125/93. 4.5 Description of the Device: The EXHALOMETER~m EX1O0 is a device that is a self… | 1997 |
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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- None of the 4 ancestors has a recall.
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 EXHALOMETERTM EX100 is intended to measure the tidal volume, minute volume and respiration rate being delivered to the patient via expiratory ports of resuscitation devices such as transport ventilators and resuscitators. The device is primarily used by Emergency Medical Technicians during emergency transport operations and can also be used for intra-hospital transport. The device is used for indicating how well the resuscitator is functioning. In addition, the device is used for periodically checking the adequacy of the ventilation effort of patients who have initiated spontaneous respiration. The EXHALOMETER can also be used for training and developing resuscitation techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051279 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051279: Caldyne, Inc. Exhalometer EX100, Model EX100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051279
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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