510(k) · Cleared
ClearedEms Pulmonary Function Testing Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Engineered Medical Systems · BZG Spirometer, Diagnostic
Cleared on Mar 14, 2002 as substantially equivalent to K934475 (Pulmonary Data Services Inst., Inc., 1993) after a 176-day review. Its family tree reaches back 1 generation to 1993. 3 later devices descend from it.
- Decided
- Mar 14, 2002
- Review
- 176 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934475 (1993). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK934475 Koko Filter IIPulmonary Data Services Inst., Inc. · 1993
- This deviceK013123 Ems Pulmonary Function Testing FilterEngineered Medical Systems · 2002
- Descendant · cites it directly · 1 of its ownK051712 Model 2800 PFT FilterAir Safety, Ltd. · 2005
- Descendant · 2 generations on · 0 of its ownK142303 NeumoFilt Ergo/Neumo Filt BiteOnMedical Respiratory Devices S.L. · 2014
- Descendant · cites it directly · 0 of its ownK083233 The PFT FilterPulmonary Filtration Technologies, LLC · 2009
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934475 | Koko Filter II | Pulmonary Data Services Inst., Inc. | 1993 | — |
| 0 (this device) | K013123 | Ems Pulmonary Function Testing Filter | Engineered Medical Systems | 2002 | — |
| +1 | K051712 | Model 2800 PFT Filter | Air Safety, Ltd. | 2005 | — |
| +2 | K142303 | NeumoFilt Ergo/Neumo Filt BiteOn | Medical Respiratory Devices S.L. | 2014 | — |
| +1 | K083233 | The PFT Filter | Pulmonary Filtration Technologies, LLC | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K934475 | Koko Filter IISummary page 1…onary Function Testing Filter Common/Usual Name: PFT filter Classification Name: Filter, Bacterial, Breathing Circuit Predicate Devices: Pulmonary Data Scrvices — KoKo — K934475 {Device Description: The EMS PFT Filter is acompact, electrostatic filter with various end-fitting adaptable to various pulmonar… | 1993 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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?
For use with pulmonary function testing. To filter air between the patient’s exhaled air and the testing equipment.
Single patient use.
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/K013123 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013123: Ems Pulmonary Function Testing Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013123
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026