510(k) · Cleared
Recalled · Class III · 2023Altera Filter and HME/Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meditera Tibbi Malzeme San VE Tic AS · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Mar 16, 2020 as substantially equivalent to K151498 (Zhejiang Haisheng Medical Device Co., Ltd., 2015) after a 171-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it. It has been recalled once.
- Decided
- Mar 16, 2020
- Review
- 171 days
- Class
- Class II
- Product code
- CAH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K941381 (1994). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK941381 Hygrobac,S Hygroboy and HygrobabyMallinckrodt Medical · 1994 · Recalled
- 2 generations backK013122 Ems Electrostatic Fliter and Hme CombinationEngineered Medical Systems · 2002
- 1 generation backK151498 Breathing circuit bacterial/viral filterZhejiang Haisheng Medical Device Co., Ltd. · 2015
- This deviceK192713 Altera Filter and HME/FilterMeditera Tibbi Malzeme San VE Tic AS · 2020
- Descendant · cites it directly · 0 of its ownK230483 Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter…Passy-Muir, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K230483Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)Passy-Muir, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941381 | Hygrobac,S Hygroboy and Hygrobaby | Mallinckrodt Medical | 1994 | 1 |
| −2 | K013122 | Ems Electrostatic Fliter and Hme Combination | Engineered Medical Systems | 2002 | — |
| −1 | K151498 | Breathing circuit bacterial/viral filter | Zhejiang Haisheng Medical Device Co., Ltd. | 2015 | — |
| 0 (this device) | K192713 | Altera Filter and HME/Filter | Meditera Tibbi Malzeme San VE Tic AS | 2020 | — |
| +1 | K230483 | Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) | Passy-Muir, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (1)
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 |
|---|---|---|---|
| * | K151498 | Breathing circuit bacterial/viral filterSummary page 4…CAH - filter, bacterial, breathing circuit Class II Predicate Devices: K151498 – Zhejiang Haisheng Medical Device Co. Ltd. Device Description: The subject device is provided in two (2) configurations. •… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230483 | Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 5, 2023 | Class III | Z-1160-2023 | Process control | Incorrect expiration date on product label. The manufacturing date was listed as the expiration date. Correct expiration date is "22.07.2027" |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 8.0 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K230483 (Passy-Muir, Inc., 2023) has gone furthest, with 0 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. 2020, 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?
Filter only - For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired. Use up to 24 hours.
HME / Filter - For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired and to maintain moisture levels in the patient’s respiratory tract during anesthesia, artificial respiration and other types of assisted ventilation. Use up to 24 hours.
Environment of use – clinical setting including hospital, sub-acute, pre-hospital and home
For patient with Tidal Volumes > 300 ml.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192713 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192713: Altera Filter and HME/Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192713
Report an extraction error
Are you the manufacturer?
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