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

Johnson & Johnson Medical, Inc. — Predicate Candidate Screening

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

154 daysmedian FDA review time

579 days90th percentile

53clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K001690	PROTECTIV SAFETY BLOOD COLLECTION NEEDLE	Johnson & Johnson Medical, Inc.	2000-07-31	59	0
K982641	ADVANCED NIBP MODULE	Johnson & Johnson Medical, Inc.	1999-03-29	243	0
K983362	NU-GEL * WOUND DRESSING	Johnson & Johnson Medical, Inc.	1998-12-16	83	0
K982597	FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE	Johnson & Johnson Medical, Inc.	1998-08-20	27	0
K974080	CRITIKON SOFT BLOOD PRESSURE CUFF	Johnson & Johnson Medical, Inc.	1998-05-18	201	1
K980493	I.V. CATHETER SYSTEM	Johnson & Johnson Medical, Inc.	1998-04-28	78	0
K972498	OBSERVER * CENTRAL STATION	Johnson & Johnson Medical, Inc.	1998-02-17	229	0
K973699	ULTRALON POWDER FREE LATEX SURGICAL GLOVE	Johnson & Johnson Medical, Inc.	1997-12-16	78	0
K971569	DINAMAP MPS PORTABLE MONITOR	Johnson & Johnson Medical, Inc.	1997-09-19	143	0
K970182	DINAMAP COMPACT MONITOR	Johnson & Johnson Medical, Inc.	1997-08-18	213	0
K964556	HR POLYURETHANE PICC AND MIDLINE CATHETERS	Johnson & Johnson Medical, Inc.	1997-04-16	154	0
K970721	DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM	Johnson & Johnson Medical, Inc.	1997-03-21	22	0
K965040	INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL	Johnson & Johnson Medical, Inc.	1997-03-10	83	0
K962978	CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000	Johnson & Johnson Medical, Inc.	1997-01-07	160	0
K964016	TIELLE HYDROPOLYMER FOAM DRESSING	Johnson & Johnson Medical, Inc.	1996-12-31	85	0
K962226	PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEM	Johnson & Johnson Medical, Inc.	1996-12-23	196	0
K962986	MAXXUS POWDER FREE ORTHOPAEDIC LATEX SURGICAL GLOVES	Johnson & Johnson Medical, Inc.	1996-09-20	50	0
K955113	DINAMAP SELECT MULTI-PARAMETER SYSTEM	Johnson & Johnson Medical, Inc.	1996-08-15	281	0
K961632	MICRO-TOUCH POWDER FREE LATEX SURGICAL GLOVES	Johnson & Johnson Medical, Inc.	1996-07-03	65	0
K944587	DERMIVIEW HYPOALLERGENIC CLEAR TAPE	Johnson & Johnson Medical, Inc.	1995-10-30	406	0
K953655	J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS	Johnson & Johnson Medical, Inc.	1995-10-13	70	5
K953639	NEUTRALON BROWN LATEX SURGICAL GLOVES	Johnson & Johnson Medical, Inc.	1995-10-12	69	0
K954049	MICRO-TOUCH* LATEX SURGICAL GLOVES	Johnson & Johnson Medical, Inc.	1995-10-05	37	0
K953641	MAXXUS ORTHOPAEDIC SURGICAL GLOVES	Johnson & Johnson Medical, Inc.	1995-09-15	42	0
K930618	VAGINAL CONTINENCE DEVICE	Johnson & Johnson Medical, Inc.	1995-05-04	815	0
K933654	BLADDER NECK SUPPORT PROTHESIS FITTING KIT	Johnson & Johnson Medical, Inc.	1995-05-04	646	0
K945157	MAXXUS LP ORTHOPAEDIC LATEX SURGICAL GLOVES	Johnson & Johnson Medical, Inc.	1995-02-13	115	0
K945158	MICRO-TOUCH LP LATEX SURGICAL GLOVES	Johnson & Johnson Medical, Inc.	1995-02-13	115	0
K943900	LATEX MEDICAL GLOVE	Johnson & Johnson Medical, Inc.	1994-12-12	124	0
K943620	MICRO-TOUCH LATEX MEDICAL GLOVES	Johnson & Johnson Medical, Inc.	1994-09-09	44	0
K934608	BARRIER FABRIC 450 SURGICAL GOWN	Johnson & Johnson Medical, Inc.	1994-04-11	196	0
K932731	BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN	Johnson & Johnson Medical, Inc.	1994-04-11	308	0
K924334	CIDEX FORMULA 7* LONG-LIFE ACTIVATED DIALDEHYDE	Johnson & Johnson Medical, Inc.	1994-03-29	579	0
K923744	CIDEX PLUS 28 DAY SOLUTION	Johnson & Johnson Medical, Inc.	1994-03-29	609	0
K924434	CIDEX ACTIVATED DIALDEHYDE SOLUTION	Johnson & Johnson Medical, Inc.	1994-03-29	574	0
K934194	BARRIER LASER PLUS FACE MASK	Johnson & Johnson Medical, Inc.	1994-03-28	214	0
K935227	MAXXUS ORTHOPAEDIC LATEX SURGICAL GLOVES	Johnson & Johnson Medical, Inc.	1994-03-07	126	0
K920108	BARRIER EXTRA PROTECTION PLUS FACE MASK	Johnson & Johnson Medical, Inc.	1994-02-10	762	0
K932336	NU-GEL ISLAND WOUND DRESSING	Johnson & Johnson Medical, Inc.	1994-02-09	271	0
K921910	STERRAD CHEMICAL INDICATOR	Johnson & Johnson Medical, Inc.	1993-10-04	529	0
K915682	STERRAD 100 STERILIZATION SYSTEM	Johnson & Johnson Medical, Inc.	1993-10-01	652	0
K921909	STERRAD BI TEST PACK	Johnson & Johnson Medical, Inc.	1993-10-01	526	0
K925548	FIBRACOL COLLAGEN-ALGINATE DRESSING	Johnson & Johnson Medical, Inc.	1993-07-13	252	0
K923235	BIOCLUSIVE MVP TRANSPARENT DRESSING	Johnson & Johnson Medical, Inc.	1993-05-12	315	0
K915218	ULTRALON POWDERFREE SURGICAL GLOVES	Johnson & Johnson Medical, Inc.	1992-12-15	391	0
K921983	NU-BREDE PACKING AND DEBRIDEMENT SPONGE	Johnson & Johnson Medical, Inc.	1992-09-18	143	0
K922895	J-VAC BULB SUCTION RESERVOIR	Johnson & Johnson Medical, Inc.	1992-09-15	91	0
K920995	BARRIER DRAPE SHEET WITH SYMETRY FABRIC	Johnson & Johnson Medical, Inc.	1992-05-31	90	0
K920996	BARRIER SURGICAL GOWN WITH SYMETRY FABRIC	Johnson & Johnson Medical, Inc.	1992-05-31	90	0
K910557	BARRIER* EXTRA PROTECTION PLUS FACE MASK	Johnson & Johnson Medical, Inc.	1991-04-29	80	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