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

Ballard Medical Products · Predicate Candidate Screening

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

80 daysmedian FDA review time

222 days90th percentile

26clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K030721	QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE	Ballard Medical Products	2003-03-31	24	0
K022398	REUSABLE BRONCHIAL BIOPSY FORCEPS	Ballard Medical Products	2002-10-11	80	0
K013892	LUTZ NEEDLE	Ballard Medical Products	2002-07-11	230	0
K000495	BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES	Ballard Medical Products	2000-03-28	42	0
K993138	BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT	Ballard Medical Products	1999-10-20	30	0
K990376	BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME	Ballard Medical Products	1999-05-03	84	0
K982894	MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT	Ballard Medical Products	1998-09-11	25	0
K974630	72 HOUR USE TRACH CARE WITH MICROBAN	Ballard Medical Products	1998-03-11	89	0
K964369	TRACH CARE SET WITH MICROBAN	Ballard Medical Products	1997-02-11	102	0
K951533	EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT	Ballard Medical Products	1995-07-05	93	0
K923487	BAL CATH	Ballard Medical Products	1993-07-30	380	0
K915109	RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET	Ballard Medical Products	1992-05-08	177	0
K900273	TRACH CARE MDI ADAPTER	Ballard Medical Products	1990-08-29	222	0
K895360	C.P.A.P. VALVE AND C.P.P.A. KIT	Ballard Medical Products	1989-11-15	79	0
K895130	HEIMLICH MICRO TRACH	Ballard Medical Products	1989-11-07	82	0
K882461	O2 CARE	Ballard Medical Products	1988-11-28	166	0
K881790	SAFETY DRAIN	Ballard Medical Products	1988-06-21	56	0
K873731	SAFETY SHIELD KIT	Ballard Medical Products	1988-01-15	158	0
K873810	SAFETY SHIELD SUCTION CATHETER	Ballard Medical Products	1987-12-11	84	0
K873732	TRACH CARE START KIT	Ballard Medical Products	1987-10-13	64	0
K872621	TRACH CARE CATHETER	Ballard Medical Products	1987-09-15	71	5
K872283	ORAL SUCTION CATHETER	Ballard Medical Products	1987-08-03	48	0
K860510	NEONATE PERCUSSOR	Ballard Medical Products	1986-02-20	9	0
K843636	FOAM CARE ONE STEP PREP	Ballard Medical Products	1984-11-16	60	0
K831226	MEDICAL PRODUCTS FOAM DOUBLE SCRUB #450	Ballard Medical Products	1983-05-16	31	0
K820713	BALLARD MEDICAL PRODUCTS ELECTRO-SURG	Ballard Medical Products	1982-03-26	11	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