510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K112547Substantially Equivalent

Neo Nest

Denovo Proucts, LLC, Ft. Myers FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K112547 is the FDA 510(k) clearance record for NEO NEST, a class I device, cleared for Denovo Proucts, LLC on under FDA product code IMD (Pack, Hot Or Cold, Disposable). FDA records list one 510(k) clearance for Denovo Proucts, LLC. As of , FDA records show no recalls naming K112547.

Clearance record

Decision date
Received
(187 days to decision)
Product code
IMD Pack, Hot Or Cold, Disposable
Regulation
21 CFR 890.5710
Device class
Class I
Review panel
Physical Medicine
Applicant
Denovo Proucts, LLC 17051 Alico Commerce Ct. #3, Ft. Myers FL
510(k) summary
Statement
Third party review
No

Clearances, product code IMD

Trailing 12 months

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

FDA records show no clearances under product code IMD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IMD, 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