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

KIR · Predicate Candidate Screening

170 FDA 510(k) clearances under this product code; the 50 most recent screened below.

56 daysmedian FDA review time

130 days90th percentile

170clearances measured

K-number	Device	Applicant	Decided	Review days
K973212	FRESH CELLS WI-38	Diagnostic Hybrids, Inc.	1997-09-25	29
K973211	FRESH CELLS MV1LU	Diagnostic Hybrids, Inc.	1997-09-25	29
K973210	FRESH CELLS NCI H292	Diagnostic Hybrids, Inc.	1997-09-25	29
K973209	FRESH CELLS VERO	Diagnostic Hybrids, Inc.	1997-09-25	29
K973214	FRESH CELLS HFF	Diagnostic Hybrids, Inc.	1997-09-25	29
K973213	FRESH CELLS LLC-MK2	Diagnostic Hybrids, Inc.	1997-09-25	29
K971508	RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDN	Bio-Whittaker, Inc., A Cambrex Co.	1997-09-17	145
K972414	FRESHCELLS	Diagnostic Hybrids, Inc.	1997-08-29	63
K965047	MINK LUNG CELL CULTURE	Neogenex	1997-02-04	48
K962311	FRESHFROZENCELLS	Diagnostic Hybrids, Inc.	1996-08-29	73
K962782	FRESHFROZEN CELLS, HEP-2	Diagnostic Hybrids, Inc.	1996-08-29	43
K962780	FRESHCELLS, HEP-2	Diagnostic Hybrids, Inc.	1996-08-29	43
K962306	FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES	Diagnostic Hybrids, Inc.	1996-08-29	73
K955608	MCCOY CELL CULTURES	Vai Diagnostics, Inc.	1996-07-08	213
K960909	H292 CELL CULTURE	Neogenex	1996-05-30	86
K951461	NCI-H292 CELL CULTURE	Viromed Laboratories, Inc.	1996-05-22	419
K951440	LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE	Viromed Laboratories, Inc.	1996-05-22	420
K955921	A549 CELL CULTURE	Viratest Intl., Inc.	1996-02-16	64
K952727	MRC-5 CELL CULTURE VIAL	Viratest Intl., Inc.	1995-11-20	159
K942820	H292	Bartels, Inc.	1995-05-05	324
K943887	HUMAN NEWBORN FORESKIN CELL CULTURE	Neogenex	1994-11-28	111
K943891	RD CULTURE CELL	Neogenex	1994-11-28	111
K943885	PRIMARY RABBIT KIDNEY CELL CULTURE	Neogenex	1994-11-28	111
K943889	VERO CELL CULTURE	Neogenex	1994-11-28	111
K943884	PRIMARY MONKEY KIDNEY CELL CULTURE	Neogenex	1994-11-28	111
K943890	WI38 CELL CULTURE	Neogenex	1994-11-28	111
K943888	MDCK CELL CULTURE	Neogenex	1994-11-28	111
K943886	BGM CELL CULTURE	Neogenex	1994-11-28	111
K936271	FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE	Diagnostic Hybrids, Inc.	1994-08-26	239
K940502	FRESH FROZEN CELLS	Diagnostic Hybrids, Inc.	1994-06-16	134
K933927	HEP-2 CULTURE CELL	Neogenex	1994-03-31	233
K933923	A549 CULTURE CELL	Neogenex	1994-03-29	231
K933924	MCCOY CULTURE CELL	Neogenex	1994-03-29	231
K933925	MRC-5 CULTURE CELL	Neogenex	1994-03-29	231
K933926	LLCMK2 CULTURE CELLS	Neogenex	1994-03-29	231
K936172	RHESUS MONKEY KIDNEY CELLS (LLC-MK2)	Advanced Clinical Diagnostics	1994-02-03	42
K936169	RHESUS MONKEY KIDNEY CELLS	Advanced Clinical Diagnostics	1994-02-03	42
K936171	TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY	Advanced Clinical Diagnostics	1994-02-03	42
K934973	HELA-229/HELA CELLS	Advanced Clinical Diagnostics	1994-01-28	102
K934934	RABBIT KIDNEY CELLS - R.K.C.	Advanced Clinical Diagnostics	1994-01-28	155
K935766	PRIMARY AFRICAN GREEN MONKEY KIDNEY CELLS	Advanced Clinical Diagnostics	1994-01-24	80
K935337	RHABDOMYOSARCOMA CELLS	Advanced Clinical Diagnostics	1994-01-03	59
K935339	HELA HELA EPITHELOID CARCINOMA	Advanced Clinical Diagnostics	1994-01-03	59
K934244	HUMAN LUNG DIPLOID CELLS-MRC-5	Advanced Clinical Diagnostics	1994-01-03	130
K934245	HUMAN FORESKIN FIBROBLAST CELLS-H.F.F.	Advanced Clinical Diagnostics	1994-01-03	130
K934240	KIDNEY AFRICIAN GREEN MONKEY CELLS-VERO	Advanced Clinical Diagnostics	1994-01-03	130
K934246	LUNG DIPLOID HUMAN CELLS-WI-38	Advanced Clinical Diagnostics	1994-01-03	130
K935338	LUNG CACINOMA, HUMAN CELLS	Advanced Clinical Diagnostics	1994-01-03	59
K934242	BUFFALO GREEN MONKEY KIDNEY CELLS-B.G.M.K.	Advanced Clinical Diagnostics	1994-01-03	130
K934239	KIDNEY AFRICAN GREEN MONKEY CELLS-CV-1	Advanced Clinical Diagnostics	1994-01-03	130

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