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

Sherwood Medical Co. · Predicate Candidate Screening

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

43 daysmedian FDA review time

168 days90th percentile

191clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K981365	MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS	Sherwood Medical Co.	1998-11-25	224	0
K960982	MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRIN	Sherwood Medical Co.	1996-12-23	287	0
K962880	SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVE	Sherwood Medical Co.	1996-12-09	138	0
K960574	ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION	Sherwood Medical Co.	1996-08-05	175	0
K960677	KANGAROO JEJUNAL FEEDING SYSTEM	Sherwood Medical Co.	1996-05-13	87	0
K960632	KANGAROO FEEDING TUBE PLACMENT STYLET	Sherwood Medical Co.	1996-05-09	85	0
K955831	ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM	Sherwood Medical Co.	1996-03-28	93	0
K954429	KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT	Sherwood Medical Co.	1996-03-08	168	0
K954525	SENSI-TOUCH EPIDURAL ANESTHESIA FILTER	Sherwood Medical Co.	1996-01-19	112	0
K950201	ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER	Sherwood Medical Co.	1995-12-15	331	0
K954300	ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CA	Sherwood Medical Co.	1995-12-13	90	0
K952938	AQUAFLO BTP HYDROGEL WOUND DRESSING	Sherwood Medical Co.	1995-12-08	165	0
K951738	ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER	Sherwood Medical Co.	1995-09-29	168	1
K951737	ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER INSER	Sherwood Medical Co.	1995-09-28	167	1
K952945	AQUAFLO HYDROGEL WOUND DRESSING & PACKER	Sherwood Medical Co.	1995-08-23	58	0
K952071	ULTEC THIN HYDROCOLLOID DRESSING	Sherwood Medical Co.	1995-06-22	51	0
K950929	SENSI-TOUCH EPIDURAL ANESTHESIA TRAY	Sherwood Medical Co.	1995-05-30	90	0
K944083	MONOJECT(R) SAMPLETTE(R) COLLECTION TUBE	Sherwood Medical Co.	1995-05-26	277	0
K951515	MONOJECT VERTICAL ENTRY CHEMOTHERAPY SHARPS CONTAINER	Sherwood Medical Co.	1995-05-23	50	0
K942791	ARGYLE AQUA-SEAL CONTINUOUS AUTOTRANSFUSION CHEST DRAINAGE U	Sherwood Medical Co.	1995-05-10	330	0
K951312	MONOJECT WHITACRE POINT SPINAL NEEDLE (27G X 3 1/2)	Sherwood Medical Co.	1995-05-03	41	0
K951411	MONOJECT TUOHY POINT EPIDURAL NEEDLE (22G X 3 1/2)	Sherwood Medical Co.	1995-05-01	34	0
K951265	MONOJECT DIAMOND POINT SPINAL NEEDLE (28G X 3 1/2)	Sherwood Medical Co.	1995-04-10	20	0
K945719	ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM	Sherwood Medical Co.	1995-03-16	115	0
K945809	MONOJECT(R) VERTICAL ENTRY SHARPS CONTAINER (1 QT)	Sherwood Medical Co.	1995-03-15	107	0
K945964	KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS	Sherwood Medical Co.	1995-03-07	90	0
K945715	MONOJECT(R) PISTON SYRINGES; 3,6,12,20,35 AND 60CC SIZES	Sherwood Medical Co.	1995-03-01	100	0
K935781	ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALVE INSERTION TRAY	Sherwood Medical Co.	1995-01-27	417	0
K944814	CORVAC PLASTIC BLOOD COLLECTION TUBE	Sherwood Medical Co.	1994-12-19	81	0
K945109	MONOJECT BONE MARROW BIOPSY TRAYS	Sherwood Medical Co.	1994-11-14	27	0
K941291	MONOJECT SAMPLETTE SEPARATOR TUBE	Sherwood Medical Co.	1994-10-27	224	0
K941814	ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETER	Sherwood Medical Co.	1994-09-30	171	1
K940961	MONOJECT LUER ADAPTER	Sherwood Medical Co.	1994-09-14	196	0
K943485	MONOJECT HORIZONTAL ENTRY SHARPS CONTAINER	Sherwood Medical Co.	1994-09-09	52	0
K943496	MONOJECT TRAY SIZE SHARPS CONTAINER	Sherwood Medical Co.	1994-08-29	41	0
K942564	ARGYLE NEO-SERT	Sherwood Medical Co.	1994-08-25	86	0
K943578	MONOJECT HIGH VOLUME/CHEMOTHERAPY SHARPS CONTAINER	Sherwood Medical Co.	1994-08-23	32	0
K940058	MONOJECT BLOOD COLLECTION TUBES W/SAFETY STOPPER	Sherwood Medical Co.	1994-05-02	117	0
K940575	ASPIR-PULSE(TM) SAF-T-VENT	Sherwood Medical Co.	1994-03-22	43	0
K933510	ARGYLE TURKEL SAFETY TROCAR THORACIC CATHETER	Sherwood Medical Co.	1994-02-24	219	0
K935238	ARGYLE TURKEL SAFETY PARACENTESIS PROCEDURE TRAY	Sherwood Medical Co.	1994-02-17	108	0
K933751	LIFESHIELD BLOOD COLLECTION DEVICE	Sherwood Medical Co.	1994-02-14	195	0
K934404	MONOJECT VERTICAL ENTRY SHARPS CONTAINER	Sherwood Medical Co.	1994-02-04	148	0
K934428	ARGYLE TURKEL SAFETY PNEUMOTHORAX PROCEDURE TRAY	Sherwood Medical Co.	1993-12-30	111	0
K934723	ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM	Sherwood Medical Co.	1993-11-30	61	0
K932785	MONOJECT(R) MONOLETTOR SAFETY LANCET	Sherwood Medical Co.	1993-09-29	112	0
K925556	ARGYLE ASPIR-FLEX SUCTION CATHETER	Sherwood Medical Co.	1993-07-30	269	0
K924511	MONOJECT(R) 6 CC SAFETY SYRINGE	Sherwood Medical Co.	1993-07-29	328	0
K930847	ARGYLE TURKEL SAFETY THORACENTESIS PROC. TRAY	Sherwood Medical Co.	1993-07-12	144	0
K925453	SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT I	Sherwood Medical Co.	1993-07-12	257	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