510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851666Substantially Equivalent

Medi-Comp Neonatal Oxygen Hood

Medicomp, Inc., Anoka MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851666 is the FDA 510(k) clearance record for MEDI-COMP NEONATAL OXYGEN HOOD, a class I device, cleared for Medicomp, Inc. on under FDA product code BYL (Tent, Oxygen). FDA records list 23 510(k) clearances for Medicomp, Inc., from to . As of , FDA records show no recalls naming K851666.

Clearance record

Decision date
Received
(105 days to decision)
Product code
BYL Tent, Oxygen
Regulation
21 CFR 868.5700
Device class
Class I
Review panel
Anesthesiology
Applicant
Medicomp, Inc. 411 Freemont St., Anoka MN
Third party review
No

Clearances, product code BYL

Trailing 12 months

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

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