510(k) · Cleared
ClearedPulmodyne CHF Flow Generator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulmodyne · BYE Attachment, Breathing, Positive End Expiratory Pressure
Cleared on May 9, 2008 as substantially equivalent to K982283 (Caradyne, Ltd., 1999) after a 99-day review. Its family tree reaches back 2 generations to 1980. 1 of the 8 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- May 9, 2008
- Review
- 99 days
- Class
- Class II
- Product code
- BYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K801883 (1980). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK801883 Peep Face MaskVital Signs, Inc. · 1980
- 1 generation backK982283 Whisperflow Oxygen Flow Generator - Adjustable Model WF 8500…Caradyne, Ltd. · 1999
- This deviceK080256 Pulmodyne CHF Flow Generator SystemPulmodyne · 2008
- Descendant · cites it directly · 0 of its ownK123957 Pneupac Parapac PlusSmiths Medical International, Ltd. · 2013 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK122610 Plaxtron Cpap System, Model CH-FFM-87XX/CH-FFM-88XX SeriesSen MU Technology Co., Ltd. · 2013
Class I recalls in this family
- K123957 Pneupac Parapac Pluscites it directly · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K801883 | Peep Face Mask | Vital Signs, Inc. | 1980 | — |
| −1 | K982283 | Whisperflow Oxygen Flow Generator - Adjustable Model WF 8500 Whisperflow… | Caradyne, Ltd. | 1999 | — |
| 0 (this device) | K080256 | Pulmodyne CHF Flow Generator System | Pulmodyne | 2008 | — |
| +1 | K123957 | Pneupac Parapac Plus | Smiths Medical International, Ltd. | 2013 | Class I |
| +1 | K122610 | Plaxtron Cpap System, Model CH-FFM-87XX/CH-FFM-88XX Series | Sen MU Technology Co., Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 1 |
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.
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K982283 | Whisperflow Oxygen Flow Generator - Adjustable Model WF 8500 Whisperflow Oxygen Flow…Summary page 1…Attachment Positive End Expiratory Pressure BYE - 868.5965 Predicate Devices: Caradyne - Whisperflow - K982283 Device Description: The Pulmodyne CHF Flow Generator is a venturi type oxygen / air mixture delivery device which provides CPAP… | 1999 |
What descends from it? (2)
2 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)
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.
- K123957Pneupac Parapac PlusSmiths Medical International, Ltd. · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 16 Class I recalls
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 18.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K123957 (Smiths Medical International, Ltd., 2013) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K982283.
How does its category compare?
All BYE devicesBYE Attachment, Breathing, Positive End Expiratory Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · BYE
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · BYE
117in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BYE
1in 2015
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BYE
7in 2025
MAUDE reports naming product code BYE, 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 | — | 4 | 8 |
| 2008 | 1 | — | 2 | 3 |
| 2009 | 3 | 155 | 0 | 1 |
| 2010 | 1 | — | 0 | 4 |
| 2011 | 3 | 117 | 0 | 2 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 8 |
| 2015 | 0 | — | 1 | 4 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 (1) | — |
What is it indicated for?
To provide CPAP to spontaneously breathing adult patients in the hospital and pre-hospital (EMS) environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080256: Pulmodyne CHF Flow Generator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080256
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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