Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Richards Medical Co., Inc. — Predicate Candidate Screening

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

67 daysmedian FDA review time

155 days90th percentile

71clearances measured

K-number	Device	Applicant	Decided	Review days
K896106	ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS	Richards Medical Co., Inc.	1990-06-25	248
K900628	MODULAR HIP SYSTEM	Richards Medical Co., Inc.	1990-05-09	90
K896580	UNI-POLAR HEAD	Richards Medical Co., Inc.	1990-02-15	90
K895241	INTRAMEDULLARY HIP SCREW	Richards Medical Co., Inc.	1990-01-04	136
K884824	TRICON-M TOTAL KNEE SYSTEM	Richards Medical Co., Inc.	1989-11-21	368
K896204	ZIRCONIA CERAMIC HEAD ADD'L SIZES	Richards Medical Co., Inc.	1989-11-20	25
K895242	PAPPAS TRI-FLANGE VENTILATION TUBE	Richards Medical Co., Inc.	1989-11-17	88
K893377	RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS	Richards Medical Co., Inc.	1989-11-16	199
K885069	ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED)	Richards Medical Co., Inc.	1989-09-01	267
K892366	POROUS GENESIS STEMMED TIBIAL COMPONENT	Richards Medical Co., Inc.	1989-07-19	104
K890132	POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP.	Richards Medical Co., Inc.	1989-07-19	188
K885036	POROUS COATED GENESIS FEMORAL COMPONENT	Richards Medical Co., Inc.	1989-04-19	135
K884263	ROGOZINSKI SPINAL SYSTEM	Richards Medical Co., Inc.	1988-12-29	79
K884457	MODULAR COLLARED HJD TOTAL HIP SYSTEM	Richards Medical Co., Inc.	1988-11-17	24
K882244	RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT	Richards Medical Co., Inc.	1988-06-23	23
K881769	HJD CALCAR REPLACEMENT PROSTHESIS	Richards Medical Co., Inc.	1988-06-22	65
K881143	IMPULSE TVC (RICHARDS, OMNI, MARCON)	Richards Medical Co., Inc.	1988-05-18	62
K881117	RESUBMITTING OF HJD TOTAL HIP SYSTEM	Richards Medical Co., Inc.	1988-04-29	51
K880284	ADDVANTAGE:TVC MARCON	Richards Medical Co., Inc.	1988-02-26	32
K880286	OMNI ITC TYPE HEARING AID MODEL U-IMPULSE SP	Richards Medical Co., Inc.	1988-02-23	29
K880285	RICHARDS ITC TYPE HEARING AID MODEL IMPULSE SP	Richards Medical Co., Inc.	1988-02-23	29
K874619	SPECTRON EF ACETABULAR COMPONENT	Richards Medical Co., Inc.	1988-02-17	100
K874868	OPTI-FIX COLLARED FEMORAL COMPONENTS	Richards Medical Co., Inc.	1988-01-26	60
K875156	STAINLESS STEEL ORTHOPAEDIC CABLE SYSTEM	Richards Medical Co., Inc.	1988-01-20	36
K874215	ENDOSCOPES FOR SINUS SURGERY	Richards Medical Co., Inc.	1988-01-04	80
K874707	POST AURICULAR HEARING AID 46PP-PC SUMMIT	Richards Medical Co., Inc.	1987-12-11	24
K872645	AIR CONDUCTION IN-THE-EAR HEARING AID UA/115/SCR	Richards Medical Co., Inc.	1987-12-08	155
K873300	SERVICE MASTER (IMPULSE)	Richards Medical Co., Inc.	1987-12-08	112
K873797	TI-FIT TOTAL HIP SYSTEM	Richards Medical Co., Inc.	1987-11-02	45
K873559	U-IMPULSE TVC AIR CONDUCTION HEARING AID	Richards Medical Co., Inc.	1987-10-14	42
K873560	U-IMPULSE AIR CONDUCTION IN-THE-CANAL HEARING AID	Richards Medical Co., Inc.	1987-09-29	27
K871146	GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS)	Richards Medical Co., Inc.	1987-07-31	130
K870128	HARTFORD TOTAL HIP SYSTEM (TRI-WEDGE)	Richards Medical Co., Inc.	1987-05-13	121
K871608	RODRIGUEZ NAIL	Richards Medical Co., Inc.	1987-05-08	14
K870877	BIO-VENT REUTER BOBBIN TUBE	Richards Medical Co., Inc.	1987-03-26	23
K864857	OPTI-FIX ACETABULAR COMPONENT	Richards Medical Co., Inc.	1987-03-24	103
K870961	RICHARDS EXTERNAL FIXATION SYSTEM	Richards Medical Co., Inc.	1987-03-19	9
K870129	VENTILATION TUBES WITH HYDROGEL COATING	Richards Medical Co., Inc.	1987-02-10	29
K864444	SHEA CUPPED TORP WITH HYDROXYLAPATITE FLANGE	Richards Medical Co., Inc.	1987-02-06	86
K864443	EGG-TOP TORP AND EGG-TOP PORP	Richards Medical Co., Inc.	1987-02-02	82
K863237	HYDROXYLAPATITE BONE GRAFT MATERIAL	Richards Medical Co., Inc.	1986-12-29	130
K863360	NEOMED NON GEL-R TOTAL ADHESIVE CONDUCT. ELECTRODE	Richards Medical Co., Inc.	1986-09-12	10
K862314	HIP CONTINUOUS PASSIVE MOTION MACHINE	Richards Medical Co., Inc.	1986-07-15	27
K861369	INCUS/STAPES PROSTHESIS	Richards Medical Co., Inc.	1986-07-14	94
K862225	INTERNATIONAL TOTAL HIP SYSTEM	Richards Medical Co., Inc.	1986-07-11	30
K860275	TI-FIT ACETABULAR COMPONENT	Richards Medical Co., Inc.	1986-04-03	66
K855183	COFIELD SHOULDER SYSTEM	Richards Medical Co., Inc.	1986-03-26	90
K860635	OPTI-FIX TOTAL HIP SYSTEM	Richards Medical Co., Inc.	1986-03-14	22
K854791	BIO-FIT HIP SYSTEM	Richards Medical Co., Inc.	1986-02-27	90
K854325	TRICON UNICOMPARTMENTAL KNEE SYSTEM	Richards Medical Co., Inc.	1985-12-09	42

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