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

GKL — Predicate Candidate Screening

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

71 daysmedian FDA review time

162 days90th percentile

130clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K152776	Glocyte Automated Cell Counter System	Advanced Instruments, Inc.	2016-05-27	245	0
K091539	IQ 200 URINE ANALIZER BODY FLUIDS MODULE	Iris Diagnostics	2010-08-31	462	0
K071652	HEMOCUE WBC SYSTEM	Hemocue AB	2007-10-25	129	0
K051693	MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AU	Bayer Healthcare, LLC	2005-12-07	167	0
K050235	IQ 200 URINE ANALYZER BODY FLUIDS MODULE	Iris International, Inc.	2005-03-23	50	0
K032677	SYSMEX POCH-100I	Sysmex America, Inc.	2004-02-11	166	1
K022331	ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD	Bayer Diagnostics Corp.	2002-09-11	55	0
K001683	SYSMEX R-500	Sysmex Corporation of America	2000-08-21	81	0
K991070	COULTER Z2 ANALYZER	Coulter Corp.	1999-05-11	41	0
K981950	SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-350	Sysmex Corp.	1998-11-03	153	0
K981761	SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER	Sysmex Corp.	1998-08-14	87	0
K971998	ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM	Bayer Corp.	1997-08-29	91	2
K964375	SYSMEX SE/RAM-1	Sysmex Corp.	1997-03-13	132	0
K962988	COULTER GEN-S SYSTEM	Coulter Corp.	1996-10-30	90	4
K954607	RETICULOCYTE METHOD	Bayer Corp.	1996-08-30	331	0
K954006	YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANA	Intl. Remote Imaging Systems	1996-03-12	200	0
K952308	COULTER Z 1	Coulter Corp.	1995-10-06	142	0
K934539	THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FL	Intl. Remote Imaging Systems	1994-03-30	194	0
K930685	TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.)	Heraeus Kulzer, Inc.	1993-06-22	132	0
K923121	QBC HEMACAN HEMATOLOGY SYSTEM	Bd Becton Dickinson Vacutainer Systems Preanalytic	1992-09-22	88	0
K920719	IVOS ANALYZER	Hamilton Thorne Research	1992-06-29	132	0
K914256	YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU	Intl. Remote Imaging Systems	1992-05-01	221	0
K912494	SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER	Toa Medical Electronics USA, Inc.	1991-09-10	97	0
K911173	SYSMEX F-310	Toa Medical Electronics USA, Inc.	1991-07-26	149	0
K911172	SYSMEX F-610	Toa Medical Electronics USA, Inc.	1991-07-26	149	0
K910849	SYSMEX F-810	Toa Medical Electronics USA, Inc.	1991-07-26	149	0
K910679	GENESIS I AUTOMATED CELL COUNTER	Alicia Diagnostics, Inc.	1991-05-07	81	0
K894539	SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER	Toa Medical Electronics USA, Inc.	1989-09-26	68	0
K885332	COULTER FLOW RETICULOCYTE REAGENT	Coulter Electronics, Inc.	1989-02-22	56	0
K884618	NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS	Nova Biomedical Corp.	1989-01-24	81	0
K885132	FACSMATE SAMPLE HANDLING DEVICE	Bd Becton Dickinson Vacutainer Systems Preanalytic	1988-12-28	16	0
K884471	KVM BLOOD CELL COUNTER	Kvm Instruments, Inc.	1988-12-27	63	0
K880636	RETICCOUNT SOFTWARE	Bd Becton Dickinson Vacutainer Systems Preanalytic	1988-03-21	34	0
K874320	CELLECT LABTRAK SOFTWARE	Instrumentation Laboratory CO	1988-01-27	98	0
K872145	CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000)	Cryo Corp.	1987-11-13	162	0
K873271	DIGICELL 300 SYSTEM	Contraves Medical Instruments, Inc.	1987-11-06	81	0
K873172	HAMILTON-THORN MOTILITY ANALYZER HTM-2000	Hamilton Thorne Research	1987-11-06	87	0
K873252	DIGICELL 500	Contraves Medical Instruments, Inc.	1987-11-06	81	0
K872166	FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT	Bd Becton Dickinson Vacutainer Systems Preanalytic	1987-09-30	117	0
K871830	NAPSAC(TM)	Beecher Medical Diagnostic Instrumentation	1987-09-09	121	0
K873103	TECHNICON H*1 JR.(TM) SYSTEM	Technicon Instruments Corp.	1987-08-28	21	0
K870603	SYSTEM 9000 AUTOMATED CELL COUNTER	Baker Instructions Corp.	1987-03-31	48	0
K863332	ATAC 4300 HEMATOLOGY CELL COUNTER	Turpen Laboratory Systems, Inc.	1986-09-29	33	0
K862374	CELLECT 8E AUTOMATED BLOOD CELL COUNTERS	Instrumentation Laboratory CO	1986-09-04	72	0
K863290	IL CELLECT 7	Instrumentation Laboratory CO	1986-09-04	10	0
K863085	COULTER COUNTER MODEL T-540	Coulter Electronics, Inc.	1986-09-04	23	0
K863084	COULTER COUNTER MODEL T-890	Coulter Electronics, Inc.	1986-09-04	23	0
K863291	IL CELLECT 8	Instrumentation Laboratory CO	1986-09-04	10	0
K861780	COULTER COUNTER MODEL S PLUS JUNIOR	Coulter Electronics, Inc.	1986-08-06	90	0
K860586	PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS	Diagnostic Technology, Inc.	1986-05-07	77	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