510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091862Substantially Equivalent

Nessi Spacer

Pharmacaribe LLC, Bonita Springs FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091862 is the FDA 510(k) clearance record for NESSI SPACER, a class II device, cleared for Pharmacaribe on under FDA product code NVO (Spacer, Direct Patient Interface). FDA's definition for product code NVO reads: "Spacers are devices that are used with nebulizers and metered dose inhalers that are comprised of a reservior into which an aerosol medication is dispensed. A spacer uses an open mouthpiece. Spacers are intended to minimize delivery of...". FDA records list 4 510(k) clearances for Pharmacaribe, from to . As of , FDA records show no recalls naming K091862.

Clearance record

Decision date
Received
(150 days to decision)
Product code
NVO Spacer, Direct Patient Interface
Regulation
21 CFR 868.5630
Device class
Class II
Review panel
Anesthesiology
Applicant
Pharmacaribe 24301 Woodsage Dr., Bonita Springs FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NVO

Trailing 12 months

FDA records hold no clearances under product code NVO in the trailing twelve months.

FDA records show no clearances under product code NVO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NVO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260