510(k) · Cleared
ClearedExhalation Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intersurgical Incorporated · CBP Valve, Non-Rebreathing
Cleared on Jun 4, 2014 as substantially equivalent to K984481 (Intersurgical, Inc., 1999) after a 328-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it.
- Decided
- Jun 4, 2014
- Review
- 328 days
- Class
- Class II
- Product code
- CBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K984481 (1999). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K210992Altech® Exhalation Valve (Single Limb and Dual Limb)Meditera Tibbi Malzeme San VE Tic AS · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K984481 | Exhalation Valve | Intersurgical, Inc. | 1999 | — |
| 0 (this device) | K132143 | Exhalation Valve | Intersurgical Incorporated | 2014 | — |
| +1 | K210992 | Altech® Exhalation Valve (Single Limb and Dual Limb) | Meditera Tibbi Malzeme San VE Tic AS | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 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
- #3 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 |
|---|---|---|---|
| * | K984481 | Exhalation ValveSummary page 1…Device: The. 1923500 &, 1924501 MK3' exhalation valve and the 1924504 MK3b exhalation valves are substantially equivalent to the Intersurgical 1922500 exhalation valve (K984481). The predicate device can be used on a single limb breathing systems. The valve sits on a T-piece connected at the patient end o… | 1999 |
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 |
|---|---|---|---|
| K210992 | Altech® Exhalation Valve (Single Limb and Dual Limb) | 2021 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K210992 (Meditera Tibbi Malzeme San VE Tic AS, 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CBP devicesCBP Valve, Non-Rebreathing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 used to control Inspiratory pressure and expel the expired air from a patient being venilated via a single limb breathing system. The exhalation valve arid single limb breathing systems are used with adults/pediatrics and prescribed by n Physician. A pediatric population is defined as 10 kg to 40 kg in weight. The product is not for use in neonates. The device can be used within hospitals and for home care use. It is a single patient use device and can be used for a maximum of 30 days.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132143 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132143: Exhalation Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132143
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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