510(k) · Cleared
ClearedAir Safety Hepa and Non-Hepa Filters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Air Safety, Ltd. · CAH Filter, Bacterial, Breathing-Circuit
Cleared on May 13, 2004 as substantially equivalent to K013089 (Engineered Medical Systems, 2002) and 2 other predicates after a 230-day review. Its family tree reaches back 2 generations to 1994. 8 of the 39 devices in its family, counting itself, have a Class I recall. 29 later devices descend from it.
- Decided
- May 13, 2004
- Review
- 230 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K941381 (1994). 9 ancestors in all. 29 later devices descend from it, 4 citing it directly. 8 of the 39 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK941381 Hygrobac,S Hygroboy and HygrobabyMallinckrodt Medical · 1994 · Recalled
- 1 generation backK013089 Ems Hepa Filter and Hme CombinationsEngineered Medical Systems · 2002
- This deviceK033008 Air Safety Hepa and Non-Hepa FiltersAir Safety, Ltd. · 2004
- Descendant · cites it directly · 22 of its ownK060705 Carina HomeDraeger Medical B.V. · 2006 · Recalled
- Descendant · 2 generations on · 20 of its ownK103167 Stellar 150Resmed Germany, Inc. · 2011
- Descendant · 3 generations on · 8 of its ownK113053 Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- Descendant · 3 generations on · 7 of its ownK113288 Vpap ST-aResmed, Ltd. · 2012
- Descendant · 4 generations on · 6 of its ownK121623 Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 29 · See all- K060705Carina HomeDraeger Medical B.V. · 2006 · cites it directly22descendants
- K103167Stellar 150Resmed Germany, Inc. · 2011 · 2 generations on20descendants
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 3 generations on8descendants
- K113288Vpap ST-aResmed, Ltd. · 2012 · 3 generations on7descendants
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941381 | Hygrobac,S Hygroboy and Hygrobaby | Mallinckrodt Medical | 1994 | 1 |
| −1 | K013089 | Ems Hepa Filter and Hme Combinations | Engineered Medical Systems | 2002 | — |
| 0 (this device) | K033008 | Air Safety Hepa and Non-Hepa Filters | Air Safety, Ltd. | 2004 | — |
| +1 | K060705 | Carina Home | Draeger Medical B.V. | 2006 | 1 |
| +2 | K103167 | Stellar 150 | Resmed Germany, Inc. | 2011 | — |
| +3 | K113053 | Bipap a 30 Ventilatory Support System | Respironics, Inc. | 2012 | Class I |
| +3 | K113288 | Vpap ST-a | Resmed, Ltd. | 2012 | — |
| +4 | K121623 | Bipap a 40 Ventilatory Support System | Respironics, Inc. | 2012 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 2 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 2 |
| 2013 | 2 | 1 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 1 |
| 2021 | 1 | 1 |
| 2022 | 2 | 1 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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.
8 devices in this family have a Class I recall. 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013089 | Ems Hepa Filter and Hme CombinationsSummary page 1…Filter, Bacterial, Breathing Circuit, CAH Predicate Devices: Engineered Medical Systems - HEPA - K013089 Non-HEPA - K013 122 Smiths Filter - K002201… | 2002 |
| * | K013122 | Ems Electrostatic Fliter and Hme CombinationSummary page 1…edicate Devices: Engineered Medical Systems - HEPA - K013089 Non-HEPA - K013 122 Smiths Filter - K002201 NPB D/X7 - K964540 and K98437… | 2002 |
| * | K002201 | Electrostatic Hydrophobic Breathing FilterSummary page 1…HEPA - K013089 Non-HEPA - K013 122 Smiths Filter - K002201 NPB D/X7 - K964540 and K984379 IDevice Description The Air Safety HEPA and Non-HEPA filt… | 2001 |
| Kept off the family tree | K964540 | FDA’s K964540 is Nellcor Puritan Bennett, 740 Ventilator System Our reading of the summary gave K964540, FDA’s number for Nellcor Puritan Bennett, 740 Ventilator System (Puritan Bennett Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “NPB D/X7”. Kept off the family tree. Summary page 1…Non-HEPA - K013 122 Smiths Filter - K002201 NPB D/X7 - K964540 and K984379 IDevice Description The Air Safety HEPA and Non-HEPA filters are available in multiple sizes and shapes, and inco… | 1997 |
| Kept off the family tree | K984379 | FDA’s K984379 is Nellcor Puritan Bennett, 760 Ventilator System Our reading of the summary gave K984379, FDA’s number for Nellcor Puritan Bennett, 760 Ventilator System (Puritan Bennett Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “NPB D/X7”. Kept off the family tree. Summary page 1…Non-HEPA - K013 122 Smiths Filter - K002201 NPB D/X7 - K964540 and K984379 IDevice Description The Air Safety HEPA and Non-HEPA filters are available in multiple sizes and shapes, and incorporate stan… | 1998 |
What descends from it? (29)
See all 294 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (8 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K072002Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55Draeger Medical AG & Co. KG · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA · 2022 · 3 generations on · ◆ in the 2022 descendants bar of FIG. 14 Class I recalls
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K122715Stellar 150Resmed Germany, Inc. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K060705 (Draeger Medical B.V., 2006) has gone furthest, with 22 descendants of its own.
- 4 other devices also cite its predicate K013089.
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 | — |
What is it indicated for?
Anesthesia / Respiratory Filters
For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is desired.
Model - HEPA filter 3000/04 - Single patient use for exhalation limb of circuit on NPB 700 series ventilators
Models - HEPA filters - 6500/01, 6888/01, 8222/01, 8444/01
Model - Non-HEPA filters - 4000/01
Single patient use up to 24 hours. Patient tidal volumes > 150 ml, when applicable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033008: Air Safety Hepa and Non-Hepa Filters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033008
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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