510(k) · Cleared
ClearedAltech® Exhalation Valve (Single Limb and Dual Limb)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meditera Tibbi Malzeme San VE Tic AS · CBP Valve, Non-Rebreathing
Cleared on Dec 23, 2021 as substantially equivalent to K132143 (Intersurgical Incorporated, 2014) after a 265-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Dec 23, 2021
- Review
- 265 days
- Class
- Class II
- Product code
- CBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K984481 (1999). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 CBP? 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 CBP device
- #1 K241366 QualityFlow O2 Series (QualityFLOW O2)…score 8.3 · 1 generation · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K132143 | Exhalation ValveSummary page 4…gulation Name: Non-rebreathing Valve Product code: CBP Predicate Device: Exhalation valve - K132143 Manufacturer: Intersurgical Regulation Number: 21 CFR 868.5870 Regulation Name… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 15.3 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All CBP devicesCBP Valve, Non-Rebreathing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · CBP
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CBP
129in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBP
No recall names CBP since 2007.
Adverse event reports per year · CBP
1in 2021
MAUDE reports naming product code CBP, 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 | 1 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 6 |
| 2010 | 2 | — | 0 | 3 |
| 2011 | 3 | 129 | 0 | 2 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 11 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The exhalation valves are intended to be used in ventilator circuits consistent with the indicated use of the ventilator to which they are attached.
The single limb model directs flow and allows for pressure monitoring and may be used within hospitals and for home care use.
The dual limb model regulates flow and is for use in hospitals and for home care use.
The exhalation valve are used with adults, pediatrics, and neonates.
The exhalation valves are for single patient use and can be used for a maximum of 30 days
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210992 · printed Nov 3, 2026
Cite this page
510(k) Report. “K210992: Altech® Exhalation Valve (Single Limb and Dual Limb).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K210992
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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