Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Tecnol New Jersey Wound Care, Inc. · Predicate Candidate Screening

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

36 daysmedian FDA review time

112 days90th percentile

35clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K913043	MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS	Tecnol New Jersey Wound Care, Inc.	1991-08-23	64	0
K911891	FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK	Tecnol New Jersey Wound Care, Inc.	1991-07-12	74	0
K911907	FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS	Tecnol New Jersey Wound Care, Inc.	1991-07-08	69	0
K896193	TECNOL LAZER(TM) SURGICAL MASK	Tecnol New Jersey Wound Care, Inc.	1990-02-27	125	0
K894205	TECNOL SILK STRIP	Tecnol New Jersey Wound Care, Inc.	1989-07-25	36	0
K893702	TECNOL GAITERS PRODUCT NUMBER 47725-010	Tecnol New Jersey Wound Care, Inc.	1989-06-23	36	0
K891187	TECNOL NASO-GASTRIC TUBE HOLDER	Tecnol New Jersey Wound Care, Inc.	1989-05-30	85	0
K891178	TECNOL SECURE-ALL TUBE HOLDER	Tecnol New Jersey Wound Care, Inc.	1989-05-23	78	0
K884440	TECNOL VARIABLE TENSION BANDAGE	Tecnol New Jersey Wound Care, Inc.	1989-01-17	88	0
K882640	TECNOL SECURE-ALL PELVIC TRACTION BELT	Tecnol New Jersey Wound Care, Inc.	1988-07-27	30	0
K882641	TECNOL CATHETER LEG STRAP	Tecnol New Jersey Wound Care, Inc.	1988-07-12	15	0
K882128	TECNOL TIGER PAWS PRODUCT NUMBER 47705-010	Tecnol New Jersey Wound Care, Inc.	1988-06-15	26	0
K874894	TECNOL LASER SURGICAL MASK	Tecnol New Jersey Wound Care, Inc.	1988-03-28	118	0
K880757	TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD	Tecnol New Jersey Wound Care, Inc.	1988-03-11	15	0
K873368	TECNOL COMPRESSION KNEE DRESSING	Tecnol New Jersey Wound Care, Inc.	1987-12-11	112	0
K874608	TECNOL FLUID SHIELD SURGICAL MASK	Tecnol New Jersey Wound Care, Inc.	1987-12-02	23	0
K873785	TECNOL FOG-FREE SURGICAL MASK W/DERMA-TOUCH TAPE	Tecnol New Jersey Wound Care, Inc.	1987-11-02	46	0
K873830	TECNOL SURGEON'S CAP	Tecnol New Jersey Wound Care, Inc.	1987-10-23	32	0
K870056	TECNOL CLASSIC CONE MASK	Tecnol New Jersey Wound Care, Inc.	1987-02-06	30	0
K861189	TECNOL SECURE-ALL FETAL MONITOR STRAP	Tecnol New Jersey Wound Care, Inc.	1986-04-08	8	0
K831148	HIGH FILTRATION ISO-MASK	Tecnol New Jersey Wound Care, Inc.	1984-07-17	466	2
K832194	SURGICAL FACE MASK-DISPOSABLE	Tecnol New Jersey Wound Care, Inc.	1983-07-26	18	0
K831149	PERSONAL KNEE CRUTCH PAD	Tecnol New Jersey Wound Care, Inc.	1983-05-03	25	0
K813030	O.R. ARMBOARD COVER	Tecnol New Jersey Wound Care, Inc.	1982-01-18	82	0
K802850	TECNOL O.R. TOURNIQUET COVER	Tecnol New Jersey Wound Care, Inc.	1981-01-13	62	0
K802849	TECNOL TELEMETRY UNIT POUCH	Tecnol New Jersey Wound Care, Inc.	1980-12-16	34	0
K801272	TECNOL QUICK RELEASE LIMB HOLDER	Tecnol New Jersey Wound Care, Inc.	1980-06-17	20	0
K791859	TECNOL STIRRUPS STRAP	Tecnol New Jersey Wound Care, Inc.	1979-10-04	16	0
K790699	TECNOL BODY HOLDER	Tecnol New Jersey Wound Care, Inc.	1979-06-01	50	0
K770635	PROTECTOR, HEEL & ELBOW	Tecnol New Jersey Wound Care, Inc.	1977-05-23	49	0
K760782	TECNOL PATIENT USE ICE PACK	Tecnol New Jersey Wound Care, Inc.	1976-12-02	58	0
K760772	DISPOSABLE ABDOMINAL BINDER	Tecnol New Jersey Wound Care, Inc.	1976-11-03	30	0
K760307	BEDPAN, SINGLE PATIENT USE, TECNOL	Tecnol New Jersey Wound Care, Inc.	1976-08-11	16	0
K760308	I.V. SUPPORT, TECNOL ARMBOARD	Tecnol New Jersey Wound Care, Inc.	1976-08-11	16	0
K760309	LIMB HOLDER, TECNOL REMINDER	Tecnol New Jersey Wound Care, Inc.	1976-08-09	14	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