510(k) · Cleared
ClearedAir Safety Hepa, Model 3500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Air Safety, Ltd. · MOD Accessory To Continuous Ventilator (Respirator)
Cleared on Jun 3, 2004 as substantially equivalent to K990177 (Nellcor Puritan Bennett, Inc., 1999) and 1 other predicate after a 77-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Jun 3, 2004
- Review
- 77 days
- Class
- Class II
- Product code
- MOD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K894316 (1989). 10 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894316 | Amadeus Ventilator | Hamilton Medical, Inc. | 1989 | — |
| −1 | K990177 | Nellcor Puritan Bennett Achieva Ventilator and Report Generator | Nellcor Puritan Bennett, Inc. | 1999 | — |
| 0 (this device) | K040712 | Air Safety Hepa, Model 3500 | Air Safety, Ltd. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 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 MOD? 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 MOD device
- #1 K261360 EasyCare Tx 2score 14.6 · 10 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 |
|---|---|---|---|
| * | K990177 | Nellcor Puritan Bennett Achieva Ventilator and Report GeneratorSummary page 1…Inlet filter Classification Name: Accessory to a Continuous Ventilator (Respirator), MOD Predicate Devices: NPB Achieva ventilator - K990177 EMS filter- K013089 IDevice Description Model 3500/01 is a replacement part for the ventil… | 1999 |
| * | K013089 | Ems Hepa Filter and Hme CombinationsSummary page 1…sory to a Continuous Ventilator (Respirator), MOD Predicate Devices: NPB Achieva ventilator - K990177 EMS filter- K013089 IDevice Description Model 3500/01 is a replacement part for the ventilator. The Inlet Filter removes particles of 0.3 micron si… | 2002 |
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 15 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K990177.
How does its category compare?
All MOD devicesMOD Accessory To Continuous Ventilator (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MOD
3so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · MOD
125in 2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOD
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOD
1in 2022
MAUDE reports naming product code MOD, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 3 | 125 | 1 | — |
What is it indicated for?
Model 3500/01 is a replacement part for the ventilator. The Inlet Filter removes particles of 0.3 micron size (or larger) from entering the ventilator.
It is a HEPA grade particulate filter for use with the NPB Achieva or LP 10 ventilators. The filter is in the gas flow pathway.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040712 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040712: Air Safety Hepa, Model 3500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040712
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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