510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K922288Substantially Equivalent

Holder, Pediatric Position

Yamashita and Hemsley Business Trust, Medford OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922288 is the FDA 510(k) clearance record for HOLDER, PEDIATRIC POSITION, a class I device, cleared for Yamashita and Hemsley Business Trust on under FDA product code BWN (Table And Attachments, Operating-Room). FDA records list one 510(k) clearance for Yamashita and Hemsley Business Trust. As of , FDA records show no recalls naming K922288.

Clearance record

Decision date
Received
(271 days to decision)
Product code
BWN Table And Attachments, Operating-Room
Regulation
21 CFR 878.4950
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Yamashita and Hemsley Business Trust 2834 Rosewood St., Medford OR
510(k) summary
Statement
Third party review
No

Clearances, product code BWN

Trailing 12 months

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

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