510(k) · Cleared
ClearedThermoShield HME Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flexicare Medical Limited. · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Mar 22, 2017 as substantially equivalent to K964382 (Gibeck, Inc., 1997) and 1 other predicate after a 120-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Mar 22, 2017
- Review
- 120 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K952084 (1995). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK952084 Humid-Vent Filter PediGibeck, Inc. · 1995
- This deviceK163300 ThermoShield HME FilterFlexicare Medical Limited. · 2017
- Descendant · cites it directly · 0 of its ownK241339 Besmed Bacterial Filter and HMEFBesmed Health Business Corp · 2024
- Descendant · cites it directly · 0 of its ownK210352 GGM Breathing Circuit Bacterial FilterGreat Group Medical Co, Ltd. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952084 | Humid-Vent Filter Pedi | Gibeck, Inc. | 1995 | — |
| 0 (this device) | K163300 | ThermoShield HME Filter | Flexicare Medical Limited. | 2017 | — |
| +1 | K241339 | Besmed Bacterial Filter and HMEF | Besmed Health Business Corp | 2024 | — |
| +1 | K210352 | GGM Breathing Circuit Bacterial Filter | Great Group Medical Co, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K964382 | Humid-Vent Filter Compact Angled (18402)/Humid-Vent Filter Compact Straight (19402)Summary page 4…umid-Vent Filter Compact Straight” which was cleared for marketing by 510(k) No K964382 for adult population. And, · Gibeck “Hu… | 1997 |
| * | K952084 | Humid-Vent Filter PediSummary page 4…And, · Gibeck “Humid-Vent Filter Pedi” which was cleared for marketing by 510(k) K952084 for pediatric population. Device Description: Flexicare’s ThermoShield HME Filters are designed to prevent the t… | 1995 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All CAH devicesCAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Flexicare’s ThermoShield HME (Heat and Moisture Exchange) Filters are intended to reduce the transmission of bacteria and viruses to/from a patient, and to maintain moisture levels in the patient’s respiratory tract during anesthesia, artificial respiration and other types of assisted ventilation. An HMEF is normally positioned at the patient end of the breathing system between the circuit Y-piece and the catheter mount or patient airway device.…
Read the full statement (122 words)
Flexicare’s ThermoShield HME (Heat and Moisture Exchange) Filters are intended to reduce the transmission of bacteria and viruses to/from a patient, and to maintain moisture levels in the patient’s respiratory tract during anesthesia, artificial respiration and other types of assisted ventilation.
An HMEF is normally positioned at the patient end of the breathing system between the circuit Y-piece and the catheter mount or patient airway device.
Flexicare’s ThermoShield HME Filters are single use devices for use on a single patient for up to 24hrs and are available in Adult and Mini (pediatric) sizes.
Flexicare’s ThermoShield HME Filters are designed to be used in pre-hospital, hospital and homecare environments by trained personnel.
Expert clinical judgment must be used in assessing patient humidification requirements.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163300 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163300: ThermoShield HME Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163300
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