510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K852100Substantially Equivalent

The Henley Board S.i.d. Spinal Immobilization Devi

Henley Board, Inc., Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852100 is the FDA 510(k) clearance record for THE HENLEY BOARD S.I.D. SPINAL IMMOBILIZATION DEVI, a class II device, cleared for Henley Board, Inc. on under FDA product code FPD (Tube, Feeding). FDA records list one 510(k) clearance for Henley Board, Inc. As of , FDA records show no recalls naming K852100.

Clearance record

Decision date
Received
(70 days to decision)
Product code
FPD Tube, Feeding
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Henley Board, Inc. 213 Crabb Ave., Rockville MD
Third party review
No

Clearances, product code FPD

Trailing 12 months

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

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