510(k) · Cleared
ClearedKoko Filter II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulmonary Data Services Inst., Inc. · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Oct 21, 1993 after a 37-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Oct 21, 1993
- Review
- 37 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 5 citing it directly.
- This deviceK934475 Koko Filter IIPulmonary Data Services Inst., Inc. · 1993
- Descendant · cites it directly · 3 of its ownK013123 Ems Pulmonary Function Testing FilterEngineered Medical Systems · 2002
- Descendant · cites it directly · 2 of its ownK043148 All Flow Pulmonary Function FilterAlliance Tech Medical, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 1 of its ownK051712 Model 2800 PFT FilterAir Safety, Ltd. · 2005
- Descendant · 3 generations on · 0 of its ownK142303 NeumoFilt Ergo/Neumo Filt BiteOnMedical Respiratory Devices S.L. · 2014
- Descendant · cites it directly · 0 of its ownK121382 Westmed, Inc.'S Blockaide Filter [21 CFR 807.87(a)]Westmed, Inc. · 2012
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K013123Ems Pulmonary Function Testing FilterEngineered Medical Systems · 2002 · cites it directly3descendants
- K043148All Flow Pulmonary Function FilterAlliance Tech Medical, Inc. · 2004 · cites it directly2descendants
- K051712Model 2800 PFT FilterAir Safety, Ltd. · 2005 · 2 generations on1descendant
- K142303NeumoFilt Ergo/Neumo Filt BiteOnMedical Respiratory Devices S.L. · 2014 · 3 generations on0descendants
- K121382Westmed, Inc.'S Blockaide Filter [21 CFR 807.87(a)]Westmed, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934475 | Koko Filter II | Pulmonary Data Services Inst., Inc. | 1993 | — |
| +1 | K013123 | Ems Pulmonary Function Testing Filter | Engineered Medical Systems | 2002 | — |
| +1 | K043148 | All Flow Pulmonary Function Filter | Alliance Tech Medical, Inc. | 2004 | 1 |
| +2 | K051712 | Model 2800 PFT Filter | Air Safety, Ltd. | 2005 | — |
| +3 | K142303 | NeumoFilt Ergo/Neumo Filt BiteOn | Medical Respiratory Devices S.L. | 2014 | — |
| +1 | K121382 | Westmed, Inc.'S Blockaide Filter [21 CFR 807.87(a)] | Westmed, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CAH? 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 CAH device
- #1 K251583 Ambu® Virobac II® Exhalation Filterscore 11.6 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
5 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?
- Of its descendants, K013123 (Engineered Medical Systems, 2002) has gone furthest, with 3 descendants of its own.
How does its category compare?
All CAH devicesCAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAH
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CAH
237in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAH
1in 2025
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · CAH
77in 2025
MAUDE reports naming product code CAH, 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 | 2 | — | 0 | 32 |
| 2008 | 1 | — | 0 | 27 |
| 2009 | 4 | 111 | 0 | 18 |
| 2010 | 5 | 216 | 2 | 40 |
| 2011 | 3 | 281 | 0 | 9 |
| 2012 | 3 | 212 | 0 | 16 |
| 2013 | 1 | — | 1 | 47 |
| 2014 | 4 | 250 | 1 | 98 |
| 2015 | 2 | — | 0 | 51 |
| 2016 | 0 | — | 0 | 34 |
| 2017 | 1 | — | 1 | 29 |
| 2018 | 0 | — | 0 | 33 |
| 2019 | 2 | — | 0 | 30 |
| 2020 | 2 | — | 0 | 33 |
| 2021 | 2 | — | 0 | 56 |
| 2022 | 3 | 204 | 6 (6) | 67 |
| 2023 | 3 | 237 | 0 | 40 |
| 2024 | 2 | — | 0 | 51 |
| 2025 | 0 | — | 1 (1) | 77 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K934475 · printed Nov 4, 2026
Cite this page
510(k) Report. “K934475: Koko Filter II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K934475
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026