510(k) · Cleared
Recalled · Class II · 2021Optichamber Diamond Valved Holding Chamber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics New Jersey, Inc. · NVP Holding Chambers, Direct Patient Interface
Cleared on Aug 9, 2011 as substantially equivalent to K052332 (Trudell Medical Intl., 2005) after a 189-day review. Its family tree reaches back 1 generation to 2005. It has been recalled once.
- Decided
- Aug 9, 2011
- Review
- 189 days
- Class
- Class II
- Product code
- NVP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K052332 (2005). No later device cites it as a predicate yet.
- Root · 1 generation backK052332 Aerochamber Z-Stat Plus Valved Holding ChamberTrudell Medical Intl. · 2005
- This deviceK110293 Optichamber Diamond Valved Holding ChamberRespironics New Jersey, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052332 | Aerochamber Z-Stat Plus Valved Holding Chamber | Trudell Medical Intl. | 2005 | — |
| 0 (this device) | K110293 | Optichamber Diamond Valved Holding Chamber | Respironics New Jersey, Inc. | 2011 | — |
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 NVP? 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 NVP device
- #1 K242667 AeroChamber2go Anti-Static Valved Holding…score 9.0 · 2 generations · 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 |
|---|---|---|---|
| * | K052332 | Aerochamber Z-Stat Plus Valved Holding ChamberSummary page 2…rmation: Identification of legally marketed device which we claim substantial equivalence to: AeroChamber Plus Z-Stat Valved Holding Chamber K052332 Trudell Medical International. 725 Third Street London, Ontario Canada, N5V 5G4 4. Device Descri… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 16, 2021 | Class II | Z-1941-2021 | Environmental control | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K052332.
How does its category compare?
All NVP devicesNVP Holding Chambers, Direct Patient Interface: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NVP
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NVP
235in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NVP
No recall names NVP since 2007.
Adverse event reports per year · NVP
3in 2024
MAUDE reports naming product code NVP, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 235 | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OptiChamber Diamond Valved Holding Chamber device is intended to be used by patients who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose inhalers. The intended environments for use include the home, hospitals and clinics.
For Single Patient Use
Recommended Patient Population:
OptiChamber Diamond: Age 5 and up
OptiChamber Diamond with Small LiteTouch mask: 0 to 18 months
OptiChamber Diamond with Medium LiteTouch mask: 1 to 5 years
OptiChamber Diamond with Large LiteTouch mask: 5 years +
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110293 · printed Nov 3, 2026
Cite this page
510(k) Report. “K110293: Optichamber Diamond Valved Holding Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110293
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