510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880253Substantially Equivalent

Blakemore Retainer

Mizuho Orthopedic Systems Inc, Hayward CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880253 is the FDA 510(k) clearance record for BLAKEMORE RETAINER, a class II device, cleared for Orthopedic Systems, Inc. on under FDA product code FEF (Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression). FDA records list 95 510(k) clearances for MIZUHO ORTHOPEDIC SYSTEMS, INC., from to . As of , FDA records show no recalls naming K880253.

Clearance record

Decision date
Received
(51 days to decision)
Product code
FEF Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Orthopedic Systems, Inc. 1897 National Ave., Hayward CA
Third party review
No

Clearances, product code FEF

Trailing 12 months

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

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