510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962182Substantially Equivalent

Burlew Infant Hood

Promedic, Inc., Mccordsville IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962182 is the FDA 510(k) clearance record for BURLEW INFANT HOOD, a class I device, cleared for Promedic, Inc. on under FDA product code FOG (Hood, Oxygen, Infant). FDA records list 16 510(k) clearances for Promedic, Inc., from to . As of , FDA records show no recalls naming K962182.

Clearance record

Decision date
Received
(39 days to decision)
Product code
FOG Hood, Oxygen, Infant
Regulation
21 CFR 868.5700
Device class
Class I
Review panel
Anesthesiology
Applicant
Promedic, Inc. 6329 W. Waterview Ct., Mccordsville IN
510(k) summary
Summary
Third party review
No

Clearances, product code FOG

Trailing 12 months

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

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