Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

FQO — Predicate Candidate Screening

35 FDA 510(k) clearances under this product code; the 50 most recent screened below.

77 daysmedian FDA review time

200 days90th percentile

35clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K240598	Maestro System (REF100)	Moon Surgical	2024-06-03	91	0
K221410	Maestro Platform	Moon Surgical	2022-12-02	200	0
K090136	STERIS CMAX XLT SURGICAL TABLE	STERIS Corporation	2009-03-20	58	4
K972810	OPT80 THE TRANSPORTABLE (OPT80)	O.P.T. USA, Inc.	1997-08-26	29	0
K971988	ALLEN, ULTRA AND SMART SOCKETS	Allen Medical Systems, Inc.	1997-07-11	43	0
K971307	AMSCO SURGICAL TABLE	STERIS Corporation	1997-06-27	80	0
K963506	TENET RADIOLUCENT HAND TABLE	Tenet Medical Engineering	1997-01-09	128	0
K961886	DRAGER GEMINA WALL-MOUNTED WORKPLACE	Alm Surgical Equipment, Inc.	1996-07-30	76	0
K961742	DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTE	Alm Surgical Equipment, Inc.	1996-07-26	81	0
K955750	TELETOM	Berchtold Holding GmbH	1996-02-08	52	0
K953980	KREUZER CEILING MOUNTED SUPPORT SYSTEMS, KLINOPORT	Kreuzer Corp.	1995-11-16	85	0
K951854	LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORY	Leonard Medical, Inc.	1995-06-21	61	0
K950192	SKYTRON SKYBOOM SERIES	Skytron, Div. the Kmw Group, Inc.	1995-04-03	75	3
K926463	RITTERMODEL 75 EVOLUTION UNIV POW EXAM TABLE/ACCES	Midmark Corp.	1994-10-21	666	0
K942486	IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE	Mdt Corp., Inc.	1994-08-10	77	0
K942043	DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032E	Alm Surgical Equipment, Inc.	1994-07-13	76	0
K941150	MDT SHAMPAINE 5100B AND 5100E SURGICAL TABLES	Mdt Technology For Life	1994-06-10	92	0
K940068	STRYKER OPERATING ROOM TABLE	Stryker Medical	1994-05-05	119	0
K936308	ENDEX ENDOSCOPIC POSITIONING SYSTEM	Andronic Devices, Ltd.	1994-03-31	101	0
K926525	BETASTAR 1131.02 MOBILE OPERATING TABLE	Stierlen-Maquet AG	1993-10-12	286	0
K930493	QUANTUM 3080 SURGICAL TABLE	American Sterilizer Co.	1993-06-22	141	0
K932186	BYPASS LEG POSITIONER	Voss Medical Products	1993-06-01	27	0
K924700	FISK HEADREST	Rhino Mfg.	1993-01-15	120	0
K921297	DRAGER DVE 4000 SERIES SYSTEM	Alm Surgical Equipment, Inc.	1992-11-27	255	0
K921143	PNEUMO-WEDGE	Kansas Creative Devices, Inc.	1992-09-11	184	0
K920890	OPERATING TABLE SYSTEM-BETAMAQUET 1140	Stierlen-Maquet AG	1992-07-02	141	0
K922371	SPINAL POSITIONING FRAME	Rhino Mfg.	1992-06-04	15	0
K921626	TELETOM(R)	Berchtold Holding GmbH	1992-05-05	29	0
K915141	712 PLASTIC SURGERY TABLE & ACCESORIES	Midmark Corp.	1992-01-09	57	0
K882660	GENERAL SURGICAL TABLE AND ACCESSORIES	American Sterilizer Co.	1988-07-25	27	0
K880227	ARTHROBOT(TM) LOWER LIMB POSITIONER	Andronic Devices, Ltd.	1988-02-18	29	0
K864295	DR.500O OPERATING TABLE	Koken Mfg Company, Inc.	1986-11-19	19	0
K864325	DR7700 OPERATING TABLE	Koken Mfg Company, Inc.	1986-11-19	16	0
K841115	CHARLES/MCINTYRE GIANT BREAK TABLE	Surgi-Quip Inc.U	1984-05-09	55	0
K831086	CEILING MOUNTED SUPPORT	Amsco Co.	1983-08-12	130	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda