510(k) · Cleared
ClearedAgachamber Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aga Plastic Ind. Com. Ltda. · NVP Holding Chambers, Direct Patient Interface
Cleared on Apr 29, 2011 as substantially equivalent to K070674 (Trudell Medical Intl., 2007) after a 351-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Apr 29, 2011
- Review
- 351 days
- Class
- Class II
- Product code
- NVP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K070674 (2007). No later device cites it as a predicate yet.
- Root · 1 generation backK070674 Aerochamber Plus Anti-Static Valved Holding Chamber with Flow-VU…Trudell Medical Intl. · 2007
- This deviceK101348 Agachamber SpacerAga Plastic Ind. Com. Ltda. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K070674 | Aerochamber Plus Anti-Static Valved Holding Chamber with Flow-VU Inspiratory… | Trudell Medical Intl. | 2007 | — |
| 0 (this device) | K101348 | Agachamber Spacer | Aga Plastic Ind. Com. Ltda. | 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 |
|---|---|---|---|
| * | K070674 | Aerochamber Plus Anti-Static Valved Holding Chamber with Flow-VU Inspiratory Flow…Summary page 1…Information: a) Legally Marketed Equivalent Device: Aerochamber Plus Anti-Static Valved Hold Manufactured by Trudell Medical International with 510k Number: K070674. Product code: NVP 6. AgaChamber Spacer Description: AgaChamber Spacer is composed of a conical chamber with… | 2007 |
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?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate K070674.
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 AgaChamber Spacer is intended to be used by patients, who are under the care or treatment of a licensed healthcare provider or physician. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, prescribed by a physician or healthcare professional. The device has been developed for use, with or without mask, in accordance with necessity and medical orientation. The intended environments for use include home, hospitals and clinics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101348 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101348: Agachamber Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101348
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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