510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K895913Substantially Equivalent

Standard Nebulizer Heater

Seamless Div., Professional Medical Products, Ocala FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895913 is the FDA 510(k) clearance record for STANDARD NEBULIZER HEATER, a class II device, cleared for Seamless Div., Professional Medical Products on under FDA product code CAF (Nebulizer (Direct Patient Interface)). FDA records list one 510(k) clearance for Seamless Div., Professional Medical Products. As of , FDA records show no recalls naming K895913.

Clearance record

Decision date
Received
(73 days to decision)
Product code
CAF Nebulizer (Direct Patient Interface)
Regulation
21 CFR 868.5630
Device class
Class II
Review panel
Anesthesiology
Applicant
Seamless Div., Professional Medical Products 1909 NE 25th Ave., Ocala FL
Third party review
No

Clearances, product code CAF

Trailing 12 months
4 clearances under product code CAF in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CAF, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260