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

Busse Hospital Disposables, Inc. · Predicate Candidate Screening

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

78 daysmedian FDA review time

175 days90th percentile

31clearances measured

K-number	Device	Applicant	Decided	Review days
K120002	I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE	Busse Hospital Disposables, Inc.	2012-06-26	175
K093909	BUSSE SURGICAL DRAPES IV	Busse Hospital Disposables, Inc.	2010-05-06	135
K092212	BUSSE SURGICAL DRAPES III	Busse Hospital Disposables, Inc.	2009-10-09	79
K082297	BUSSE SURGICAL DRAPE	Busse Hospital Disposables, Inc.	2008-12-09	119
K073222	MODIFICATION TO:SPECIALTY NEEDLES	Busse Hospital Disposables, Inc.	2008-04-09	146
K070465	BUSSE EPIDURAL CATHETER	Busse Hospital Disposables, Inc.	2007-07-19	153
K063018	GLASS LOSS OF RESISTANCE SYRINGE	Busse Hospital Disposables, Inc.	2007-01-22	112
K061394	SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE	Busse Hospital Disposables, Inc.	2006-09-06	110
K061570	I-STYLE BONE MARROW ASPIRATION NEEDLE	Busse Hospital Disposables, Inc.	2006-07-03	27
K052843	BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE	Busse Hospital Disposables, Inc.	2006-04-17	192
K032432	BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER	Busse Hospital Disposables, Inc.	2003-08-28	22
K021055	BUSSE UMBILICAL CORD CLAMP CUTTER	Busse Hospital Disposables, Inc.	2002-04-29	28
K010835	POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRI	Busse Hospital Disposables, Inc.	2001-04-30	41
K963260	DRESSING CHANGE TRAYS	Busse Hospital Disposables, Inc.	1996-11-22	94
K953019	HYDROPHILIC FOAM DRESSING	Busse Hospital Disposables, Inc.	1995-09-15	78
K952948	SALINE DRESSING	Busse Hospital Disposables, Inc.	1995-08-16	51
K952334	DRESSING CHANGE TRAY	Busse Hospital Disposables, Inc.	1995-07-14	57
K950560	SALINE SOLUTINE, STERILE	Busse Hospital Disposables, Inc.	1995-05-30	111
K941845	BUSE STAFF PROTECTION GOWNS AND KITS	Busse Hospital Disposables, Inc.	1995-05-10	391
K940720	BUSSE ISOLATION AND PROCEDURAL MASKS	Busse Hospital Disposables, Inc.	1994-11-02	257
K935835	BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES	Busse Hospital Disposables, Inc.	1994-01-12	36
K902297	BUSSE BAC/SHIELD	Busse Hospital Disposables, Inc.	1990-08-17	86
K900479	STERILE LACERATION TRAY CAT. #749	Busse Hospital Disposables, Inc.	1990-02-13	12
K881312	LAMINARIA	Busse Hospital Disposables, Inc.	1988-05-23	56
K874306	INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE	Busse Hospital Disposables, Inc.	1988-03-22	154
K875058	STERILE MUCUS SPECIMEN TRAP, MODELS 406 & 407	Busse Hospital Disposables, Inc.	1988-02-12	65
K874186	BOWL, SPONGE, DISPOSABLE, STERILE & NON-STERILE	Busse Hospital Disposables, Inc.	1987-12-29	76
K863712	I.V. START KIT, STERILE, DISPOSABLES	Busse Hospital Disposables, Inc.	1986-10-22	29
K861711	SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE	Busse Hospital Disposables, Inc.	1986-05-16	11
K843496	DRAPE SURGICAL UTILITY DRAPE STERILE	Busse Hospital Disposables, Inc.	1984-10-31	55
K830890	SURGICAL FACE MASK	Busse Hospital Disposables, Inc.	1983-04-27	37

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