510(k) · Cleared
ClearedExceleron Bacterial Filters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exceleron Medical · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Feb 26, 2014 as substantially equivalent to K091363 (Ag Industries, 2010) and 1 other predicate after a 267-day review. Its family tree reaches back 8 generations to 1994.
- Decided
- Feb 26, 2014
- Review
- 267 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K933081 (1994). 18 ancestors in all, the oldest K792097 (1979). No later device cites it as a predicate yet.
- Root · 8 generations backK933081 Oxlife Oxygen ConcentratorOxlife, Inc. · 1994
- 7 generations backK955549 Oxlife Oxygen ConcentratorsOxlife, Inc. · 1996
- 6 generations backK963042 Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L. · 1996
- 5 generations backK013931 Omni Oxygen System, Model 1000Sequal Technologies, Inc. · 2002 · Recalled
- 4 generations backK042262 Integra Oxygen Concentrator, Model 6323A-OM-10Sequal Technologies, Inc. · 2004
- 3 generations backK043006 Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model…Respironics, Inc. · 2005
- 2 generations backK061426 Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25…Porous Media Corp. · 2006
- 1 generation backK091363 Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950…Ag Industries · 2010
- This deviceK131626 Exceleron Bacterial FiltersExceleron Medical · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K933081 | Oxlife Oxygen Concentrator | Oxlife, Inc. | 1994 | — |
| −7 | K955549 | Oxlife Oxygen Concentrators | Oxlife, Inc. | 1996 | — |
| −6 | K963042 | Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853 | Sim Italia S.R.L. | 1996 | — |
| −5 | K013931 | Omni Oxygen System, Model 1000 | Sequal Technologies, Inc. | 2002 | 1 |
| −4 | K042262 | Integra Oxygen Concentrator, Model 6323A-OM-10 | Sequal Technologies, Inc. | 2004 | — |
| −3 | K043006 | Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605 | Respironics, Inc. | 2005 | — |
| −2 | K061426 | Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47 | Porous Media Corp. | 2006 | — |
| −1 | K091363 | Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202… | Ag Industries | 2010 | — |
| 0 (this device) | K131626 | Exceleron Bacterial Filters | Exceleron Medical | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1985 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 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 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? (2)
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 |
|---|---|---|---|
| * | K091363 | Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205…Summary page 2…e facility. Substantial Equivalence: The Exceleron Bacterial Filter is substantially equivalent to the following predicate devices: * AG Industries Bacterial Filters K091363 * Porous Media Oxygen Concentrator Filters K06 1426 Technological Characteristics: Technically from a design and mechanism of… | 2010 |
| * | K061426 | Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47Summary page 2…cterial Filter is substantially equivalent to the following predicate devices: * AG Industries Bacterial Filters K091363 * Porous Media Oxygen Concentrator Filters K06 1426 Technological Characteristics: Technically from a design and mechanism of action standpoint, the Exceleron Bacterial Filters are… | 2006 |
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 20 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 18 ancestors have a recall of any class.
How does its category compare?
All CAH devicesCAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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 | — |
What is it indicated for?
Exceleron Medical bacterial filters are single use replacement filters intended for use in oxygen concentrator machines to help remove contaminants, including air borne bacteria and other particulate debris from an air stream. When used with oxygen concentrator machines, the replacement filters may be used in the home, nursing home, hospital, patient care facility.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131626: Exceleron Bacterial Filters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131626
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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