510(k) · Cleared
ClearedClear-Guard II, Clear-Therm Hmef, Clear-Therm Hmef W/ Flextube, Clear Guard 11 W/ Gas Monitoring Port
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intersurgical, Inc. · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Jun 15, 1999 after an 85-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 of the 17 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it.
- Decided
- Jun 15, 1999
- Review
- 85 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 2 citing it directly. 6 of the 17 devices in this family, counting this one, have a Class I recall.
- This deviceK990949 Clear-Guard II, Clear-Therm Hmef, Clear-Therm Hmef W/ Flextube…Intersurgical, Inc. · 1999
- Descendant · cites it directly · 13 of its ownK081837 Avea VentilatorCardinal Health 207, Inc. · 2008
- Descendant · 2 generations on · 11 of its ownK092847 840 Ventilator System with Expanded Neomode OptionCovidien, Formerly Nellcor Puritan Bennett, Inc. · 2010
- Descendant · 3 generations on · 7 of its ownK151252 Puritan Bennett 840 Series Ventilator SystemCovidien LP · 2016
- Descendant · 4 generations on · 5 of its ownK181166 Trilogy EvoRespironics, Inc. · 2019 · Recalled (Class I)
- Descendant · 5 generations on · 2 of its ownK193586 Vivo 45 LSBreas Medical AB · 2021 · Recalled (Class I)
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 16 · See all- K081837Avea VentilatorCardinal Health 207, Inc. · 2008 · cites it directly13descendants
- K092847840 Ventilator System with Expanded Neomode OptionCovidien, Formerly Nellcor Puritan Bennett, Inc. · 2010 · 2 generations on11descendants
- K151252Puritan Bennett 840 Series Ventilator SystemCovidien LP · 2016 · 3 generations on7descendants
- K181166Trilogy EvoRespironics, Inc. · 2019 · 4 generations on5descendants
- K193586Vivo 45 LSBreas Medical AB · 2021 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990949 | Clear-Guard II, Clear-Therm Hmef, Clear-Therm Hmef W/ Flextube, Clear Guard 11… | Intersurgical, Inc. | 1999 | — |
| +1 | K081837 | Avea Ventilator | Cardinal Health 207, Inc. | 2008 | — |
| +2 | K092847 | 840 Ventilator System with Expanded Neomode Option | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2010 | — |
| +3 | K151252 | Puritan Bennett 840 Series Ventilator System | Covidien LP | 2016 | — |
| +4 | K181166 | Trilogy Evo | Respironics, Inc. | 2019 | Class I |
| +5 | K193586 | Vivo 45 LS | Breas Medical AB | 2021 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 1 |
| 2016 | 1 | 0 |
| 2017 | 1 | 1 |
| 2019 | 2 | 2 |
| 2020 | 1 | 1 |
| 2021 | 1 | 1 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
6 devices in this family have 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (16)
See all 162 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 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.
- K131252Puritan Bennett 980 Series Ventilator SystemCovidien · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 13 Class I recalls
- K162738Puritan Bennett 980 Ventilator SystemCovidien · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K181170Trilogy Evo UniversalRespironics, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 112 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC · 2020 · 5 generations on · ◆ in the 2020 descendants bar of FIG. 117 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- Of its descendants, K081837 (Cardinal Health 207, Inc., 2008) has gone furthest, with 13 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.
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?
1844 & 1844-F: For usc at the equipment connection. Desigred to reduce bacterial/viral transmission to and from patient, equipment and environmant. CAYXTIONS: When used in the sxhalation limb in conjunction with a water bath humidifier, a water trap should be placed between the filter and the patient, 1841 & 1841-T: For usc at the patient contection. Designed to reduce bacterial/viral transmission and 1o reduce the loss of patient hoat and humidity.…
Read the full statement (214 words)
1844 & 1844-F: For usc at the equipment connection. Desigred to reduce bacterial/viral transmission to and from patient, equipment and environmant. CAYXTIONS: When used in the sxhalation limb in conjunction with a water bath humidifier, a water trap should be placed between the filter and the patient,
1841 & 1841-T: For usc at the patient contection. Designed to reduce bacterial/viral transmission and 1o reduce the loss of patient hoat and humidity. CAUTIONS: This product is not suitable for patients with thick or copious sceretions; Do not use this preduct in conjunction with other humidification sourees.
1844, 1844-P, 1841, 1841-T: ISO connections: When essembling any connections use a push and twist action (o ensure a secure fit. Single patient use. Non conductive. Non sterile. Do not autoclave.
CAUTIONS: Never position any filter on the inspiratory limb downstream of & water bath bumidifier; Do not us¢ this product between the patient and a source of nebulized drugs; When nebulized drugg are administered, resistance ghould be monitored and the product should be exchanged following standard hospital procedure; All ports should remain capped when not in usc; Replace every 24 hours or more frequently if visible deterioration i observed, following standard hospital procedure; Federal law restricts this device to sale by or on the order of a physician,
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990949 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990949: Clear-Guard II, Clear-Therm Hmef, Clear-Therm Hmef W/ Flextube, Clear Guard 11 W/ Gas Monitoring Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990949
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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