510(k) · Cleared
ClearedBact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharma System AB · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Sep 26, 2021 as substantially equivalent to K903056 (Pharma Systems, Inc., 1990) and 1 other predicate after a 395-day review. Its family tree reaches back 1 generation to 1990. 1 of the 4 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Sep 26, 2021
- Review
- 395 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K903056 (1990). 2 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK903056 BacttrapPharma Systems, Inc. · 1990
- This deviceK202459 Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini…Pharma System AB · 2021
- Descendant · cites it directly · 0 of its ownK221836 Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA · 2022 · Recalled (Class I)
Class I recalls in this family
- K221836 Filter CareStar Plus, Filter SafeStar Plus…cites it directly · 2022
Most influential descendants
Showing 1 of 1 · See all- K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903056 | Bacttrap | Pharma Systems, Inc. | 1990 | — |
| 0 (this device) | K202459 | Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter… | Pharma System AB | 2021 | — |
| +1 | K221836 | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus | Drägerwerk AG & Co. KGaA | 2022 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 1 |
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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | K903056 | BacttrapSummary page 5…Page 1 of 9 1.3. Legally Marketed Predicate Device The following are the identified Predicate Devices: • Pharma Systems – K903056 – Bact Trap filters o Intended Use: Isolation of patients from bacterial and viral contamination, prev… | 1990 |
| * | K903058 | Bact-Hme (TM)Summary page 5…contamination Protection of ventilators, resuscitators, measuring devices, etc. from contamination. • Pharma Systems – K903058 – Bact HME o Intended Use: Protection of patients from excessive heat and moisture loss.… | 1990 |
| † | K090738 | Thermoflo HCH, Thermoflo Filter | 2009 |
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 |
|---|---|---|---|
| K221836 | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus Class I | 2022 | 0 |
Has anything in its family been recalled? (1 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.
- K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA · 2022 · Cites it directly · ◆ in the 2022 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
How does its category compare?
All CAH devicesCAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Bact Trap filter is a breathing system filter which is designed to reduce possible airborne or liquid-borne cross contamination with micro-organisms and particulate matter via anaesthetic or ventilator breathing systems. The Bact Trap filter may either be used on the patient side or on the device side of the ventilator anaesthetic device. The Bact HME/Bact-HME Midi/Pharma Mini is a breathing system filter and a Heat and Moisture Exchanger. The…
Read the full statement (204 words)
Bact Trap filter is a breathing system filter which is designed to reduce possible airborne or liquid-borne cross contamination with micro-organisms and particulate matter via anaesthetic or ventilator breathing systems. The Bact Trap filter may either be used on the patient side or on the device side of the ventilator anaesthetic device.
The Bact HME/Bact-HME Midi/Pharma Mini is a breathing system filter and a Heat and Moisture Exchanger. The combination ofa filter and a Heat and Moisture Exchanger offer the benefit of both product features. Heat and Moisture Exchangers are used as a conditioning system for mechanically ventilated patients whose upper airways are bypassed. In almost all cases of mechanical ventilation they are a fully valid alternative to heated humidifiers. The Bact HME/Bact-HME Midi/Pharma Mini should be used with patients who have a Tidal Volume between 50 - 1500 ml.
The Pharma MiniTmHME/Filter, Bact-HMETm filter/HME and Bact-HMETM Midi HME/Filter should be used with patients who have a Tidal Volume as follows:
* Pharma Minim and Bact-Trapm Mini 50-900ml
* Bact-HMETM Midi and Bact-Trap~m Midi between 100-1200 ml
* Bact-HMETm and Bact-Trap~m between 250-1500 ml
The products mentioned above are designed as disposable single patient use and should be changed at least every 24 hours
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202459: Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi 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/K202459
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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