510(k) · Cleared
ClearedInspirachamber Anti-Static Valved Holding Chamber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inspirx, Inc. · NVP Holding Chambers, Direct Patient Interface
Cleared on Jun 5, 2013 as substantially equivalent to K872037 (Monaghan Medical Corp., 1987) after a 90-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Jun 5, 2013
- Review
- 90 days
- Class
- Class II
- Product code
- NVP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K872037 (1987). No later device cites it as a predicate yet.
- Root · 1 generation backK872037 AerochamberMonaghan Medical Corp. · 1987
- This deviceK130598 Inspirachamber Anti-Static Valved Holding ChamberInspirx, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872037 | Aerochamber | Monaghan Medical Corp. | 1987 | — |
| 0 (this device) | K130598 | Inspirachamber Anti-Static Valved Holding Chamber | Inspirx, Inc. | 2013 | — |
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 |
|---|---|---|---|
| * | K872037 | AerochamberSummary page 1…ng Chamber Common/Usual Name: Spacer / Holding Chamber Classification Name: Holding Chambers, Direct Patient Interface NVP - CFR 868.5630 " Class I Predicate Devices: K872037 — Trudell AcroChamber Device Description: The InspiraChamber® is intended for use in the inhalation of medications delivered vi… | 1987 |
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.
- 3 other devices also cite its predicate K872037.
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. 2013, 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 InspiraChamber® Anti-Static Valved Holding Chamber is intended to be used by patients who are under the care or treatment of a licensed health care professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, (pMDIs).
Environment of use — Home, hospitals and clinics where patients may require the use of a holding chamber with pMDiIs.
The intended patient population is 3 years and older who have been prescribed pMDI medications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130598 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130598: Inspirachamber Anti-Static Valved Holding Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130598
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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