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

Mill-Rose Laboratory — Predicate Candidate Screening

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

41 daysmedian FDA review time

228 days90th percentile

46clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K983124	MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBN	Mill-Rose Laboratory	1998-10-30	52	0
K983122	MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBN	Mill-Rose Laboratory	1998-10-30	52	0
K971275	MILL-ROSE DISPOSABLE POLYPECTOMY SNARE	Mill-Rose Laboratory	1997-05-23	46	0
K962736	MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE	Mill-Rose Laboratory	1996-07-29	14	0
K960880	MILL-ROSE BLIND MICROBIOLOGY BRUSH	Mill-Rose Laboratory	1996-04-29	56	0
K954519	WANG TRANSENDOSCOPIC ASPIRATION NEEDLE	Mill-Rose Laboratory	1995-12-22	85	0
K951600	MILL-ROSE ROTATABLE POLYPECTOMY SNARE	Mill-Rose Laboratory	1995-12-18	255	0
K954745	MILL-ROSE RIGID SCOPE CLEANING BRUSHES	Mill-Rose Laboratory	1995-11-27	42	0
K951051	RITE-BITE BIOPSY FORCEPS	Mill-Rose Laboratory	1995-03-24	18	0
K951048	RITE-BITE BIOPSY FORCEPS	Mill-Rose Laboratory	1995-03-15	9	0
K946293	MILL-ROSE SCOPE CLEANING BRUSH	Mill-Rose Laboratory	1995-02-16	51	0
K950559	DIENER RETRIEVAL DEVICES	Mill-Rose Laboratory	1995-02-16	8	0
K944649	MILL-ROSE HARRELL BRONCHIAL BRUSH	Mill-Rose Laboratory	1994-11-30	70	0
K944650	WANG BRONCHIAL NEEDLE BRUSH	Mill-Rose Laboratory	1994-11-22	62	0
K942630	WANG/MILL-ROSE PLEURAL BIOPSY NEEDLE	Mill-Rose Laboratory	1994-07-12	39	0
K921680	E-Z PEG	Mill-Rose Laboratory	1994-05-06	758	0
K940521	MILL-ROSE PROTECTED TRANSLARYNGOSCOPIC CATHETER	Mill-Rose Laboratory	1994-05-04	89	0
K935858	MILL-ROSE PERCUTANEOUS PROCEDURAL KIT	Mill-Rose Laboratory	1994-02-22	76	0
K922204	MILL-ROSE PULMONARY FORCEPS	Mill-Rose Laboratory	1993-07-13	428	0
K921800	COLONOSCOPIC INJECTION NEEDLE, C-323/C-325	Mill-Rose Laboratory	1993-02-08	300	0
K914181	WANG/MILL-ROSE TRANSBRONCHIAL ASPIRATION NEEDLE	Mill-Rose Laboratory	1991-12-10	83	4
K910536	PROTECTED BRONCHOALVEOLAR LAVAGE BALLOON CATHETER	Mill-Rose Laboratory	1991-09-24	228	0
K901995	PLEURA BIOPSY DEVICE	Mill-Rose Laboratory	1990-07-10	69	0
K895420	SUCTION BIOPSY INSTRUMENT	Mill-Rose Laboratory	1990-02-09	161	0
K894326	THORACENTISIS KIT	Mill-Rose Laboratory	1989-07-24	10	0
K884857	COLONOSCOPE GUIDING TUBE DEVICE	Mill-Rose Laboratory	1989-03-17	116	0
K862725	SACCOMANNO SPECIMAN SOLUTION	Mill-Rose Laboratory	1986-08-01	15	0
K850489	ENDOSOPIC STENE MANIPULATING BALLOON	Mill-Rose Laboratory	1985-04-22	73	0
K842679	ESOPHAGEAL DILATOR SET	Mill-Rose Laboratory	1984-10-02	84	0
K833268	ENDOSCOPIC OVERTUBE	Mill-Rose Laboratory	1983-10-31	40	0
K820771	MICROBIOLOGY SPECIMEN BRUSH	Mill-Rose Laboratory	1982-05-03	41	0
K820971	DIATHERMIC HANDLE FOR BIOPSY FORCEPS	Mill-Rose Laboratory	1982-04-29	23	0
K820972	BIOPSY FORCEPS W/OVAL CUPS	Mill-Rose Laboratory	1982-04-26	20	0
K820983	HOT BIOPSY FORCEPS W/ROUND CUPS	Mill-Rose Laboratory	1982-04-26	20	0
K820967	BIOPSY FORCEPS W/ALLIGATOR TYPE CUPS	Mill-Rose Laboratory	1982-04-26	20	0
K820968	RETRIEVAL FORCEPS W/ALLIGATOR JAWS	Mill-Rose Laboratory	1982-04-26	20	0
K820980	BIOPSY FORCEPS W/OVAL CUP & NEEDLE	Mill-Rose Laboratory	1982-04-26	20	0
K820969	BIOPSY FORCEPW W/SMALL OVAL CUPS	Mill-Rose Laboratory	1982-04-26	20	0
K820970	RETRIEVAL FORCEPS W/RATTOOTHED JAWS	Mill-Rose Laboratory	1982-04-26	20	0
K820973	ENDOSCOPIC INJECTION NEEDLE	Mill-Rose Laboratory	1982-04-16	10	0
K802443	E.R.C.P. CANNULA PRODUCT	Mill-Rose Laboratory	1980-10-23	16	0
K802444	PAPILLOTOME PRODUCT	Mill-Rose Laboratory	1980-10-23	16	0
K792344	STONE AND RETRIEVAL BASKET	Mill-Rose Laboratory	1979-12-20	31	0
K792345	RETRIEVABLE FORCEPS	Mill-Rose Laboratory	1979-12-20	31	0
K792343	DIATHERMIC SNARE (CRESENT TYPE)	Mill-Rose Laboratory	1979-12-18	29	0
K791668	ENDOSCOPIC CYTOLOGY BRUSHES	Mill-Rose Laboratory	1979-10-01	34	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