510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K940132Substantially Equivalent

Podiatric Material

Crown Delta Corp., Yorktown Heights NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940132 is the FDA 510(k) clearance record for PODIATRIC MATERIAL, a class I device, cleared for Crown Delta Corp. on under FDA product code MNE (Orthosis, Moldable, Supportive, Skin Protective). FDA records list 18 510(k) clearances for Crown Delta Corp., from to . As of , FDA records show no recalls naming K940132.

Clearance record

Decision date
Received
(269 days to decision)
Product code
MNE Orthosis, Moldable, Supportive, Skin Protective
Regulation
21 CFR 890.3475
Device class
Class I
Review panel
Physical Medicine
Applicant
Crown Delta Corp. 1550 Front St., Yorktown Heights NY
510(k) summary
Statement
Third party review
No

Clearances, product code MNE

Trailing 12 months

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

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