510(k) · Cleared
ClearedModel 2800 PFT Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Air Safety, Ltd. · BZG Spirometer, Diagnostic
Cleared on Sep 1, 2005 as substantially equivalent to K013123 (Engineered Medical Systems, 2002) after a 66-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Sep 1, 2005
- Review
- 66 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K934475 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK934475 Koko Filter IIPulmonary Data Services Inst., Inc. · 1993
- 1 generation backK013123 Ems Pulmonary Function Testing FilterEngineered Medical Systems · 2002
- This deviceK051712 Model 2800 PFT FilterAir Safety, Ltd. · 2005
- Descendant · cites it directly · 0 of its ownK142303 NeumoFilt Ergo/Neumo Filt BiteOnMedical Respiratory Devices S.L. · 2014
Most influential descendants
Showing 1 of 1 · See all- K142303NeumoFilt Ergo/Neumo Filt BiteOnMedical Respiratory Devices S.L. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K934475 | Koko Filter II | Pulmonary Data Services Inst., Inc. | 1993 | — |
| −1 | K013123 | Ems Pulmonary Function Testing Filter | Engineered Medical Systems | 2002 | — |
| 0 (this device) | K051712 | Model 2800 PFT Filter | Air Safety, Ltd. | 2005 | — |
| +1 | K142303 | NeumoFilt Ergo/Neumo Filt BiteOn | Medical Respiratory Devices S.L. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 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 |
|---|---|---|---|
| * | K013123 | Ems Pulmonary Function Testing FilterSummary page 2…23-June-05 General Technical Characteristics Proposed device Predicate EMS K013123 Attribute Filter - Model 2800 Intended use For use with pulmonary function For… | 2002 |
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 |
|---|---|---|---|
| K142303 | NeumoFilt Ergo/Neumo Filt BiteOn | 2014 | 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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K142303 (Medical Respiratory Devices S.L., 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K013123.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Model 2800 is indicated for use with pulmonary function testing equipment, to filter air between the patient's exhaled air and the testing equipment.
Single patient use
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051712 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051712: Model 2800 PFT Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051712
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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