510(k) Report

510(k) · Cleared

Cleared

Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47

K061426510(k) TraditionalCleared Jun 5, 200613-day reviewClass II21 CFR 868.5260

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Porous Media Corp. · CAH Filter, Bacterial, Breathing-Circuit

Cleared on Jun 5, 2006 as substantially equivalent to K972614 (Healthdyne Technologies, Inc., 1998) and 5 other predicates after a 13-day review. Its family tree reaches back 6 generations to 1994. 2 later devices descend from it.

Decided
Jun 5, 2006
Review
13 days
Class
Class II
Product code
CAH
Recalls
None
Predicates
6

Its longest line of descent runs back 6 generations to K933081 (1994). 16 ancestors in all, the oldest K792097 (1979). 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2002: 1 other ancestor1999: 1 other ancestor1998: 1 other ancestor1995: 1 other ancestor1996: 1 other ancestor2001: 1 other ancestor1994: 1 other ancestor1979: 1 other ancestor1985: 1 other ancestor2010: 1 descendant cleared2014: 1 descendant clearedK933081 · Oxlife Oxygen Concentrator · Oxlife, Inc. · 1994K955549 · Oxlife Oxygen Concentrators · Oxlife, Inc. · 1996K963042 · Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853 · Sim Italia S.R.L. · 1996K013931 · Omni Oxygen System, Model 1000 · Sequal Technologies, Inc. · 2002 · recalled×2: 2 generations cleared close together, K042262 (2004), K043006 (2005) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 1 other ancestor3 generations back: 3 other ancestors5 generations back: 1 other ancestor 1 generation forward: 2 descendants K043006 · Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605 · Respironics, Inc. · 2005K042262 · Integra Oxygen Concentrator, Model 6323A-OM-10 · Sequal Technologies, Inc. · 2004K013931 · Omni Oxygen System, Model 1000 · Sequal Technologies, Inc. · 2002 · recalledK963042 · Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853 · Sim Italia S.R.L. · 1996K955549 · Oxlife Oxygen Concentrators · Oxlife, Inc. · 1996K933081 · Oxlife Oxygen Concentrator · Oxlife, Inc. · 1994−50
  1. Root · 6 generations backK933081 Oxlife Oxygen ConcentratorOxlife, Inc. · 1994
  2. 5 generations backK955549 Oxlife Oxygen ConcentratorsOxlife, Inc. · 1996
  3. 4 generations backK963042 Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L. · 1996
  4. 3 generations backK013931 Omni Oxygen System, Model 1000Sequal Technologies, Inc. · 2002 · Recalled
  5. 2 generations backK042262 Integra Oxygen Concentrator, Model 6323A-OM-10Sequal Technologies, Inc. · 2004
  6. 1 generation backK043006 Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model…Respironics, Inc. · 2005
  7. This deviceK061426 Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25…Porous Media Corp. · 2006
  8. Descendant · cites it directly · 1 of its ownK091363 Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950…Ag Industries · 2010
  9. Descendant · cites it directly · 0 of its ownK131626 Exceleron Bacterial FiltersExceleron Medical · 2014

Most influential descendants

Showing 2 of 2 · See all
  • K091363Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205…Ag Industries · 2010 · cites it directly1descendant
  • K131626Exceleron Bacterial FiltersExceleron Medical · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K933081Oxlife Oxygen ConcentratorOxlife, Inc.1994—
−5K955549Oxlife Oxygen ConcentratorsOxlife, Inc.1996—
−4K963042Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L.1996—
−3K013931Omni Oxygen System, Model 1000Sequal Technologies, Inc.20021
−2K042262Integra Oxygen Concentrator, Model 6323A-OM-10Sequal Technologies, Inc.2004—
−1K043006Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605Respironics, Inc.2005—
0 (this device)K061426Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47Porous Media Corp.2006—
+1K091363Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202…Ag Industries2010—
+1K131626Exceleron Bacterial FiltersExceleron Medical2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198510
199410
199510
199610
199810
199910
200110
200210
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201410
FIG. 1 — Lineage of K061426, 1994–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251583 Ambu® Virobac II® Exhalation Filterscore 11.6 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K972614Twister Oxygen Concentrator Model 600, Twister Oxygen Concentrator W/Opi Model 605
Summary page 1
…e substantially equivalent to the filters installed and used in the following oxygen concentrators: * Respironics Millennium (subject to pre-market notification K972614) and Millennium Mi0 Oxygen Concentrators (subject to pre-market notification K043006). * DeVilbiss 303 Series O…
Healthdyne Technologies, Inc.1998—
*K043006Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605
Summary page 1
…ors: * Respironics Millennium (subject to pre-market notification K972614) and Millennium Mi0 Oxygen Concentrators (subject to pre-market notification K043006). * DeVilbiss 303 Series Oxygen Concentrators (subject to pre-market notification K953815), DeVilbiss 505 Serie…
Respironics, Inc.2005—
*K9538155 LPM Oxygen Concentrator
Summary page 1
…Mi0 Oxygen Concentrators (subject to pre-market notification K043006). * DeVilbiss 303 Series Oxygen Concentrators (subject to pre-market notification K953815), DeVilbiss 505 Series Oxygen Concentrators (K991722), and DeVilbiss 515 Series Oxygen Concentrators (K991722…
Devilbiss Health Care, Inc.1995—
*K991722Devilbiss 5 Liter Oxygen Concentrator
Summary page 1
…fication K043006). * DeVilbiss 303 Series Oxygen Concentrators (subject to pre-market notification K953815), DeVilbiss 505 Series Oxygen Concentrators (K991722), and DeVilbiss 515 Series Oxygen Concentrators (K991722). * Invacare Platinum Series Oxygen Concentrators (K02…
Sunrise Medical Hhg, Inc.19991
*K020386Invacare Platinum, Models Irc 5LX and Irc 5LX02
Summary page 1
…ss 505 Series Oxygen Concentrators (K991722), and DeVilbiss 515 Series Oxygen Concentrators (K991722). * Invacare Platinum Series Oxygen Concentrators (K020386). The original component filters are approved for sale subject to the pre-market notifications outlined above. In each case the o…
Invacare Corp.20022
*K052087Breathing Filter Bacterial/Viral, Model AG7178
Summary page 2
…2 Porous Media's devices identified in this submission are substantially equivalent to AG Industries Breathing Filter BacterialNiral (K052087), such that both are used as replacement filters in medical devices. Device Description Room air is drawn into the compressor th…
Ag Industries2005—

Also cleared against K972614: 2 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K091363Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205…Ag Industries20101
K131626Exceleron Bacterial FiltersExceleron Medical20140

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 5 companies; a new generation was cleared every 1.4 years on median.
  • 3 of the 16 ancestors have a recall of any class.
  • Of its descendants, K091363 (Ag Industries, 2010) has gone furthest, with 1 descendant of its own.
  • 2 other devices also cite its predicate K972614.

How does its category compare?

All CAH devices

CAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CAH

2in 2024

2007: 22008: 12009: 42010: 52011: 32012: 32013: 12014: 42015: 22017: 12019: 22020: 22021: 22022: 32023: 32024: 22026 (partial year): 2
2007high 5 (2010) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAH

237in 2023

2009: 111 days median2010: 216 days median2011: 281 days median2012: 212 days median2014: 250 days median2022: 204 days median2023: 237 days median
2007high 281 (2011) · low 111 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CAH

1in 2025

2010: 22013: 12014: 12017: 12022: 6, 6 Class I2025: 1, 1 Class I
2007high 6 (2022) · low 0 (2007)2026

Class I (7 since 2007) Class II/III not classified

Adverse event reports per year · CAH

77in 2025

2007: 322008: 272009: 182010: 402011: 92012: 162013: 472014: 982015: 512016: 342017: 292018: 332019: 302020: 332021: 562022: 672023: 402024: 512025: 77
2007high 98 (2014) · low 9 (2011)2025

MAUDE reports naming product code CAH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—032
20081—027
20094111018
20105216240
2011328109
20123212016
20131—147
20144250198
20152—051
20160—034
20171—129
20180—033
20192—030
20202—033
20212—056
202232046 (6)67
20233237040
20242—051
20250—1 (1)77
20262—0—

What is it indicated for?

Porous Media oxygen concentrator filters are 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, patient care facility, etc.

Indications for use as stated in the FDA summary.

Also cleared against K972614

2 other devices cite the same predicate.

  • K061261L4 Oxygen ConcentratorRespironics, Inc. · 2006
  • K043006Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605Respironics, Inc. · 2005

More from Porous Media Corp.

9 FDA decisions under this applicant name. See the company

  • K062091Porous Media Humidiflow Humidifier for Universal HumidificationPorous Media Corp. · 20061 recall
  • K990276Porous Media DPB30 Series Disposable Pre-Bypass FilterPorous Media Corp. · 1999
  • K982385Porous Media DPB20 Series Disposable Pre-Bypass FilterPorous Media Corp. · 1999
  • K982127Porous Media DEF25 Disposable Respiratory FilterPorous Media Corp. · 1998
  • K965020Porous Media DBF23 Reusable Respiratory FilterPorous Media Corp. · 1997

Recent decisions in CAH

The CAH category page

  • K252643Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledTeleflex Medical Sdn. Bhd. · 2026
  • K251583Ambu® Virobac II® Exhalation FilterAmbu A/S · 2026
  • K241339Besmed Bacterial Filter and HMEFBesmed Health Business Corp · 2024
  • K222917Breathing circuit bacterial/viral filterShaoxing Haitech Medical Products Co., Ltd. · 2024
  • K230483Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)Passy-Muir, Inc. · 2023

https://510kreport.com/device/K061426 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061426: Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061426

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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