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

Concept, Inc. — Predicate Candidate Screening

83 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

38 daysmedian FDA review time

115 days90th percentile

83clearances measured

K-number	Device	Applicant	Decided	Review days
K912640	CONCEPT ENDOSTEAL FIXATION DEVICE	Concept, Inc.	1992-05-01	322
K912957	CONCEPT MICROMILL	Concept, Inc.	1991-10-04	88
K896648	CONCEPT UNICOMPARTMENTAL KNEE SYSTEM	Concept, Inc.	1990-06-05	193
K894929	STAPLE FIXATION SYSTEM	Concept, Inc.	1989-08-30	28
K892376	INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)	Concept, Inc.	1989-08-01	118
K891109	PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE	Concept, Inc.	1989-05-08	67
K881954	CONCEPT POWER SYSTEM	Concept, Inc.	1988-11-09	183
K884255	CONCEPT CCT-5200, THERMAL THERAPY SYSTEM	Concept, Inc.	1988-11-08	28
K882121	C-FLO SUCTION TUBE	Concept, Inc.	1988-06-20	32
K880414	TENDON HARVESTER	Concept, Inc.	1988-03-25	53
K874676	INTERFERENCE SCREW	Concept, Inc.	1988-03-07	115
K880413	PATELLAR TENDON GRAFT GUIDE	Concept, Inc.	1988-03-04	32
K874515	CONCEPT SUTURE NEEDLE	Concept, Inc.	1987-11-27	25
K874439	SOFT TISSUE ANCHORING SET KIT	Concept, Inc.	1987-11-20	23
K872608	HEWSON A.C.L. GUIDE SET	Concept, Inc.	1987-09-16	72
K873030	CONCEPT ARTHROSCOPIC PORTAL ROD	Concept, Inc.	1987-09-16	43
K873009	CONCEPT SWITCHING STICK	Concept, Inc.	1987-08-17	13
K872156	CONCEPT SELF COMPRESSING CANNULATED SCREW SYSTEM	Concept, Inc.	1987-07-21	47
K871037	CANCELLOUS FIXATION SCREW & WASHER FOR USE W/SCREW	Concept, Inc.	1987-03-25	8
K863396	CONCEPT INTRAVISION ARTHROSCOPE SYSTEM	Concept, Inc.	1986-09-12	9
K862659	CONCEPT ARTHROSCOPY RASP	Concept, Inc.	1986-09-02	50
K862657	CONCEPT CURETTE	Concept, Inc.	1986-07-23	9
K862658	CONCEPT ARTHROSCOPIC KNIFE	Concept, Inc.	1986-07-23	9
K853829	MENISCAL REPAIR SYSTEM	Concept, Inc.	1985-10-08	25
K851040	CONCEPT DEFRERE ELECTRODE	Concept, Inc.	1985-07-11	119
K851339	PRECISION HARVEST & INLAY INSTRUMENT SET	Concept, Inc.	1985-07-02	90
K850749	CONCEPT VIDEO IMAGING SYSTEM	Concept, Inc.	1985-05-20	84
K850423	CONCEPT SUCTION SLEEVE	Concept, Inc.	1985-03-14	38
K850714	C.A.D. PACK I -ARTHROSCOPY DRAPE PACK	Concept, Inc.	1985-03-06	12
K850645	INTRA-ARC DISPOSABLE ARTHROPLASTY BURRS	Concept, Inc.	1985-03-06	15
K850462	CONCEPT CAMERA DRAPE	Concept, Inc.	1985-02-26	20
K843925	GILL'S IRRIGATOR/ASPIRATOR NEEDLE	Concept, Inc.	1984-11-05	31
K842710	CONCEPT C-VAC	Concept, Inc.	1984-10-31	111
K841483	ALL PURPOSE ELECTROSURGICAL GENERATOR	Concept, Inc.	1984-10-23	196
K843491	CONCEPT FIBER OPTIC CANALICULUS INTUBA	Concept, Inc.	1984-10-05	29
K843490	TUBE-STAT	Concept, Inc.	1984-10-04	28
K840558	SHUTT PRECISION PROBES	Concept, Inc.	1984-04-25	77
K833856	C-LOOPS	Concept, Inc.	1984-02-04	89
K834069	ARTHROSCAN VIDEO SYSTEM	Concept, Inc.	1984-01-27	63
K833940	TORQUE PLUS CATALOG 30120	Concept, Inc.	1983-12-28	43
K833441	DRY GEL	Concept, Inc.	1983-11-29	55
K833624	SHUTT UNIVERSAL STRESS POST	Concept, Inc.	1983-11-28	45
K833076	C-FLEX MEDICAL GRADE TUBING	Concept, Inc.	1983-11-21	73
K833061	C-FLEX PENROSE DRAINAGE TUBE	Concept, Inc.	1983-11-07	59
K832362	DONALDSON-TYPE VENT TUBE	Concept, Inc.	1983-10-14	88
K832361	CONCEPT T-TUBE	Concept, Inc.	1983-10-14	88
K830800	C-LOOPS	Concept, Inc.	1983-10-04	204
K832278	LIGHT HANDLE COVER	Concept, Inc.	1983-09-29	79
K832293	ENTERNAL FEEDING TUBE	Concept, Inc.	1983-09-12	61
K830434	DISPOSABLE INTRA-ARTICULAR BLADE	Concept, Inc.	1983-04-12	62

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