510(k) · Cleared
ClearedNeumoFilt Ergo/Neumo Filt BiteOn
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Respiratory Devices S.L. · BZG Spirometer, Diagnostic
Cleared on Nov 20, 2014 as substantially equivalent to K051712 (Air Safety, Ltd., 2005) after a 94-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Nov 20, 2014
- Review
- 94 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K934475 (1993). No later device cites it as a predicate yet.
- Root · 3 generations backK934475 Koko Filter IIPulmonary Data Services Inst., Inc. · 1993
- 2 generations backK013123 Ems Pulmonary Function Testing FilterEngineered Medical Systems · 2002
- 1 generation backK051712 Model 2800 PFT FilterAir Safety, Ltd. · 2005
- This deviceK142303 NeumoFilt Ergo/Neumo Filt BiteOnMedical Respiratory Devices S.L. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K934475 | Koko Filter II | Pulmonary Data Services Inst., Inc. | 1993 | — |
| −2 | K013123 | Ems Pulmonary Function Testing Filter | Engineered Medical Systems | 2002 | — |
| −1 | K051712 | Model 2800 PFT Filter | Air Safety, Ltd. | 2005 | — |
| 0 (this device) | K142303 | NeumoFilt Ergo/Neumo Filt BiteOn | Medical Respiratory Devices S.L. | 2014 | — |
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 BZG? 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 BZG device
- #1 K251777 MESI mTABLET SPIROscore 13.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K051712 | Model 2800 PFT FilterSummary page 5…number: 21 CFR 868.1840 Device class: Class II Predicate Device: Air Safety Model 2800 PFT filter (K051712) Device Description: The MRD NeumoFilt pulmonary function filter (“PFT filter”) is a standard electrostatic filter that is place… | 2005 |
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 21 years and passes through 4 companies; a new generation was cleared every 8.4 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · BZG
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BZG
362in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZG
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZG
1in 2025
MAUDE reports naming product code BZG, 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 | 3 | 121 | 0 | 1 |
| 2008 | 3 | 209 | 0 | 0 |
| 2009 | 8 | 141 | 0 | 0 |
| 2010 | 4 | 181 | 0 | 0 |
| 2011 | 6 | 278 | 0 | 1 |
| 2012 | 3 | 59 | 0 | 2 |
| 2013 | 3 | 266 | 0 | 1 |
| 2014 | 5 | 154 | 0 | 1 |
| 2015 | 5 | 273 | 0 | 1 |
| 2016 | 4 | 235 | 0 | 1 |
| 2017 | 2 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 3 | 146 | 0 | 1 |
| 2020 | 5 | 126 | 0 | 2 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 3 |
| 2023 | 5 | 362 | 0 | 2 |
| 2024 | 2 | — | 1 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
For use with pulmonary function testing (PFT) equipment only, to filter air between the patient’s exhaled air and the testing equipment. Single patient use, disposable. Duration of use <24 hours. Environment of use: Hospital, Sub-acute facilities, Clinics, Physician offices.
For use with pulmonary function testing (PFT) equipment only, to filter air between the patient’s exhaled air and the testing equipment. Single patient use, disposable. Duration of use <24 hours. Environment of use: Hospital, Sub-acute facilities, Clinics, Physician offices.
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/K142303 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142303: NeumoFilt Ergo/Neumo Filt BiteOn.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142303
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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