510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971988Substantially Equivalent

Allen, Ultra and Smart Sockets

Allen Medical Systems, Inc., Cleveland OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971988 is the FDA 510(k) clearance record for ALLEN, ULTRA AND SMART SOCKETS, a class I device, cleared for Allen Medical Systems, Inc. on under FDA product code FQO (Table, Operating-Room, Ac-Powered). FDA records list 5 510(k) clearances for Allen Medical Systems, Inc., from to . As of , FDA records show no recalls naming K971988.

Clearance record

Decision date
Received
(43 days to decision)
Product code
FQO Table, Operating-Room, Ac-Powered
Regulation
21 CFR 878.4960
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Allen Medical Systems, Inc. 15627 Neo Pkwy., Cleveland OH
510(k) summary
Statement
Third party review
No

Clearances, product code FQO

Trailing 12 months

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

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