FQO · Class I · 21 CFR 878.4960

FDA Product Code FQO: Table, Operating-room, Ac-powered

Leading manufacturers include Alm Surgical Equipment, Inc., American Sterilizer Co. and Midmark Corp..

35
Total
35
Cleared
106d
Avg days
1983
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Table, Operating-room, Ac-powered Devices (Product Code FQO)

35 devices
1–24 of 35
Cleared Jun 03, 2024
Maestro System (REF100)
K240598
Moon Surgical
General & Plastic Surgery · 91d
Cleared Dec 02, 2022
Maestro Platform
K221410
Moon Surgical
General & Plastic Surgery · 200d
Cleared Mar 20, 2009
STERIS CMAX XLT SURGICAL TABLE
K090136
STERIS Corporation
General & Plastic Surgery · 58d
Cleared Aug 26, 1997
OPT80 THE TRANSPORTABLE (OPT80)
K972810
O.P.T. USA, Inc.
General & Plastic Surgery · 29d
Cleared Jul 11, 1997
ALLEN, ULTRA AND SMART SOCKETS
K971988
Allen Medical Systems, Inc.
General & Plastic Surgery · 43d
Cleared Jun 27, 1997
AMSCO SURGICAL TABLE
K971307
STERIS Corporation
General & Plastic Surgery · 80d
Cleared Jan 09, 1997
TENET RADIOLUCENT HAND TABLE
K963506
Tenet Medical Engineering
General & Plastic Surgery · 128d
Cleared Jul 30, 1996
DRAGER GEMINA WALL-MOUNTED WORKPLACE
K961886
Alm Surgical Equipment, Inc.
General & Plastic Surgery · 76d
Cleared Jul 26, 1996
DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM
K961742
Alm Surgical Equipment, Inc.
General & Plastic Surgery · 81d
Cleared Feb 08, 1996
TELETOM
K955750
Berchtold Holding GmbH
General & Plastic Surgery · 52d
Cleared Nov 16, 1995
KREUZER CEILING MOUNTED SUPPORT SYSTEMS, KLINOPORT
K953980
Kreuzer Corp.
General & Plastic Surgery · 85d
Cleared Jun 21, 1995
LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORY
K951854
Leonard Medical, Inc.
General & Plastic Surgery · 61d
Cleared Apr 03, 1995
SKYTRON SKYBOOM SERIES
K950192
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 75d
Cleared Oct 21, 1994
RITTERMODEL 75 EVOLUTION UNIV POW EXAM TABLE/ACCES
K926463
Midmark Corp.
General & Plastic Surgery · 666d
Cleared Aug 10, 1994
IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE
K942486
Mdt Corp., Inc.
General & Plastic Surgery · 77d
Cleared Jul 13, 1994
DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032E
K942043
Alm Surgical Equipment, Inc.
General & Plastic Surgery · 76d
Cleared Jun 10, 1994
MDT SHAMPAINE 5100B AND 5100E SURGICAL TABLES
K941150
Mdt Technology For Life
General & Plastic Surgery · 92d
Cleared May 05, 1994
STRYKER OPERATING ROOM TABLE
K940068
Stryker Medical
General & Plastic Surgery · 119d
Cleared Mar 31, 1994
ENDEX ENDOSCOPIC POSITIONING SYSTEM
K936308
Andronic Devices, Ltd.
General & Plastic Surgery · 101d
Cleared Oct 12, 1993
BETASTAR 1131.02 MOBILE OPERATING TABLE
K926525
Stierlen-Maquet AG
General & Plastic Surgery · 286d
Cleared Jun 22, 1993
QUANTUM 3080 SURGICAL TABLE
K930493
American Sterilizer Co.
General & Plastic Surgery · 141d
Cleared Jun 01, 1993
BYPASS LEG POSITIONER
K932186
Voss Medical Products
General & Plastic Surgery · 27d
Cleared Jan 15, 1993
FISK HEADREST
K924700
Rhino Mfg.
General & Plastic Surgery · 120d
Cleared Nov 27, 1992
DRAGER DVE 4000 SERIES SYSTEM
K921297
Alm Surgical Equipment, Inc.
General & Plastic Surgery · 255d

About Product Code FQO - Regulatory Context

510(k) Submission Activity

35 total 510(k) submissions under product code FQO since 1983, with 35 receiving FDA clearance (average review time: 106 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.