510(k) · Cleared
ClearedNessi Otc Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharmacaribe · NVO Spacer, Direct Patient Interface
Cleared on Sep 1, 2010 as substantially equivalent to K091862 (Pharmacaribe, 2009) after a 90-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Sep 1, 2010
- Review
- 90 days
- Class
- Class II
- Product code
- NVO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010680 (2001). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010680 | CT Spacer | Clinical Technologies, Inc. | 2001 | — |
| −1 | K091862 | Nessi Spacer | Pharmacaribe | 2009 | — |
| 0 (this device) | K101532 | Nessi Otc Spacer | Pharmacaribe | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 NVO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K091862 | Nessi SpacerSummary page 4…Holding Chambers, Direct Patient Interface NVO - CFR 868.5630 Predicate Devices: K091862 – PharmaCaribe NESSI (Rx) Spacer Primatene Mist – OTC MDI Device Description: The N… | 2009 |
| * | — | Primatene Mist – OTC MDI Named without a submission number |
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 9 years and passes through 2 companies; a new generation was cleared every 8.5 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All NVO devicesNVO Spacer, Direct Patient Interface: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NVO
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · NVO
Too few NVO 510(k)s in any year since 2007 to give a median.
Recalls per year · NVO
No recall names NVO since 2007.
Adverse event reports per year · NVO
No MAUDE report names NVO since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The NESSI OTC Spacer is intended to be used to administer aerosolized medication from pressurized Metered-Dose Inhalers, which are over-the-counter (OTC), e.g., bronchodilator / epinephrine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101532 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101532: Nessi Otc Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101532
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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