510(k) · Cleared

Cleared

Nessi Spacer

K091862510(k) TraditionalCleared Nov 20, 2009150-day reviewClass II21 CFR 868.5630

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pharmacaribe · NVO Spacer, Direct Patient Interface

Cleared on Nov 20, 2009 as substantially equivalent to K010680 (Clinical Technologies, Inc., 2001) and 1 other predicate after a 150-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: Nov 20, 2009
Review: 150 days
Class: Class II
Product code: NVO
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K010680 (2001). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK010680 CT SpacerClinical Technologies, Inc. · 2001
This deviceK091862 Nessi SpacerPharmacaribe · 2009
Descendant · cites it directly · 0 of its ownK101532 Nessi Otc SpacerPharmacaribe · 2010

Most influential descendants

Showing 1 of 1 · See all

K101532Nessi Otc SpacerPharmacaribe · 2010 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010680	CT Spacer	Clinical Technologies, Inc.	2001	—
0 (this device)	K091862	Nessi Spacer	Pharmacaribe	2009	—
+1	K101532	Nessi Otc Spacer	Pharmacaribe	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0

FIG. 1 — Lineage of K091862, 2001–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K010680	CT Spacer Summary page 1 …e: Holding Chambers, Direct Patient Interface NVO - CFR 868.5630 Predicate Devices: KO010680 - CT Spacer K070674 - Trudell AeroChamber Plus Device Description: The NESSI is a space…	Clinical Technologies, Inc.	2001	—
*	K070674	Aerochamber Plus Anti-Static Valved Holding Chamber with Flow-VU Inspiratory Flow… Summary page 1 …rface NVO - CFR 868.5630 Predicate Devices: KO010680 - CT Spacer K070674 - Trudell AeroChamber Plus Device Description: The NESSI is a spacer intended for use in the inhalation of MDIs for the therapy…	Trudell Medical Intl.	2007	—
†	K082092	Dispo-Bag Manual Resuscitator, Disposable Adjustable Peep Valve, Disposable Fixed Peep…	Galemed Corp.	2008	—

Also cleared against K010680: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K101532	Nessi Otc Spacer	Pharmacaribe	2010	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?

None of the 2 ancestors has a recall.
Of its descendants, K101532 (Pharmacaribe, 2010) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K010680.

How does its category compare?

All NVO devices

NVO Spacer, Direct Patient Interface: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · NVO

1in 2010

2007high 1 (2009) · low 0 (2007)2026

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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	1	—	0
2010	1	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The NESSI Spacer is intended to be used by patients who are under the care of treatment of a licensed healthcare professional or physician. The device is intended to be used by these patients to administer aerosolized medication from pressurized Metered-Dose Inhalers, prescribed by a physician or healthcare professional.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091862 · printed Nov 5, 2026

Cite this page

510(k) Report. “K091862: Nessi Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091862

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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