510(k) · Cleared
ClearedBact-Hme (TM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharma Systems, Inc. · BYD Condenser, Heat And Moisture (Artificial Nose)
Cleared on Nov 9, 1990 after a 121-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 5 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Nov 9, 1990
- Review
- 121 days
- Class
- Class I
- Product code
- BYD
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- This deviceK903058 Bact-Hme (TM)Pharma Systems, Inc. · 1990
- Descendant · cites it directly · 1 of its ownK202459 Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini…Pharma System AB · 2021
- Descendant · 2 generations on · 0 of its ownK221836 Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA · 2022 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK090738 Thermoflo HCH, Thermoflo FilterArc Medical, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK982239 Circuit GuardArc Medical, Inc. · 1998
Class I recalls in this family
- K221836 Filter CareStar Plus, Filter SafeStar Plus…2 generations on · 2022
Most influential descendants
Showing 4 of 4 · See all- K202459Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME…Pharma System AB · 2021 · cites it directly1descendant
- K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA · 2022 · 2 generations on0descendants
- K090738Thermoflo HCH, Thermoflo FilterArc Medical, Inc. · 2009 · cites it directly0descendants
- K982239Circuit GuardArc Medical, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K903058 | Bact-Hme (TM) | Pharma Systems, Inc. | 1990 | — |
| +1 | K202459 | Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter… | Pharma System AB | 2021 | — |
| +2 | K221836 | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus | Drägerwerk AG & Co. KGaA | 2022 | Class I |
| +1 | K090738 | Thermoflo HCH, Thermoflo Filter | Arc Medical, Inc. | 2009 | — |
| +1 | K982239 | Circuit Guard | Arc Medical, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2009 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 2 generations on · ◆ in the 2022 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Of its descendants, K202459 (Pharma System AB, 2021) has gone furthest, with 1 descendant of its own.
How does its category compare?
All BYD devicesBYD Condenser, Heat And Moisture (Artificial Nose): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BYD
FDA has decided no BYD device since 2007.
Median 510(k) review, days · BYD
Too few BYD 510(k)s in any year since 2007 to give a median.
Recalls per year · BYD
3in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · BYD
52in 2025
MAUDE reports naming product code BYD, 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 | 4 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 9 |
| 2011 | 0 | — | 1 | 7 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 1 (1) | 6 |
| 2015 | 0 | — | 1 (1) | 17 |
| 2016 | 0 | — | 0 | 18 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 0 | — | 0 | 33 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 0 | — | 1 | 35 |
| 2021 | 0 | — | 0 | 15 |
| 2022 | 0 | — | 0 | 32 |
| 2023 | 0 | — | 0 | 45 |
| 2024 | 0 | — | 3 | 10 |
| 2025 | 0 | — | 0 | 52 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K903058 · printed Nov 5, 2026
Cite this page
510(k) Report. “K903058: Bact-Hme (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K903058
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026