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

Helena Laboratories — Predicate Candidate Screening

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

56 daysmedian FDA review time

174 days90th percentile

280clearances measured

K-number	Device	Applicant	Decided	Review days
K131479	V8 SP NORMAL CONTROL, ABNORMAL CONTROL	Helena Laboratories	2013-10-07	138
K100103	SPECIALTY ASSAYED CONTROL-2	Helena Laboratories	2010-12-15	336
K061991	PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA	Helena Laboratories	2007-02-23	225
K061069	SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALEN	Helena Laboratories	2006-07-06	80
K061014	ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP	Helena Laboratories	2006-05-10	27
K050053	HEMORAM/AGGRAM ANALYZER	Helena Laboratories	2005-07-11	182
K024162	SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389	Helena Laboratories	2003-02-19	64
K023761	PLATELETWORKS, MODELS PW-A, PW-C	Helena Laboratories	2003-02-14	98
K022757	SPIFE CK KIT, MODEL 3332, 3333	Helena Laboratories	2002-10-11	52
K022455	SPIFE LD-12 KIT, MODEL 3338	Helena Laboratories	2002-10-01	67
K022333	SPIFE LIPPOROTEIN-12, MODEL 3344	Helena Laboratories	2002-08-15	28
K020914	ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770	Helena Laboratories	2002-05-23	63
K020625	SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346	Helena Laboratories	2002-05-06	69
K020467	SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452	Helena Laboratories	2002-03-29	45
K013078	ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 575	Helena Laboratories	2002-01-10	118
K013466	SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343	Helena Laboratories	2001-12-21	64
K012723	PLATELETWORKS	Helena Laboratories	2001-09-28	44
K010617	SPIFE IFE CALIBRATOR AND CONTROL KIT	Helena Laboratories	2001-03-15	14
K003359	COLOSCREEN-ES	Helena Laboratories	2000-11-27	31
K000603	SPIFE CHOLESTEROL PROFILE KIT	Helena Laboratories	2000-04-17	54
K992971	REP CHOLESTEROL PROFILE KIT	Helena Laboratories	1999-10-18	45
K992199	ACID HEMOGLOBIN KIT	Helena Laboratories	1999-09-21	83
K990998	POLYSLIT IFE KIT	Helena Laboratories	1999-06-28	95
K982426	SPIFE ALKALINE HEMOGLOBIN	Helena Laboratories	1998-12-17	157
K982639	SPIFE URINE IFE	Helena Laboratories	1998-11-04	98
K980671	COLOSCREEN-ES	Helena Laboratories	1998-05-12	81
K980650	REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLES	Helena Laboratories	1998-05-01	71
K974609	REP CHOLESTEROL PROFILE CONTROL-II	Helena Laboratories	1998-01-06	27
K973040	SPIFE IFE-6	Helena Laboratories	1998-01-02	141
K972274	SPIFE	Helena Laboratories	1997-10-27	131
K973316	REP SPE VIS-60/40 KIT	Helena Laboratories	1997-10-01	28
K962914	REP 3 QUTO-FLUR CHOLESTEROL-30	Helena Laboratories	1997-01-13	171
K964453	REP 3 FLUR SPE-60 KIT	Helena Laboratories	1996-12-23	47
K964471	REP FLUR CHOLESTEROL-60 KIT	Helena Laboratories	1996-12-23	46
K961908	THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451	Helena Laboratories	1996-12-10	208
K960571	RAPID ELECTROPHORESIS ANALYZER	Helena Laboratories	1996-10-25	260
K952321	PORCINE FACTOR VIII;C REAGENT	Helena Laboratories	1996-03-11	298
K952667	CHROM Z-HEPARIN, CAT. NO 5242	Helena Laboratories	1996-02-14	247
K952668	CHROM Z-F:VIII, CAT. NO. 5241	Helena Laboratories	1996-02-09	242
K952666	CHROM Z-PROTEIN C, CAT. NO. 5243	Helena Laboratories	1996-01-30	232
K952669	CHROM Z-PLASMINOGEN, CAT. NO. 5244	Helena Laboratories	1995-12-07	178
K951943	CHROM Z CHROMOGENIC ASSAYS	Helena Laboratories	1995-11-13	201
K951820	THROMBOPLASTIN-LI REAGENT	Helena Laboratories	1995-10-20	183
K952252	ADP REAGENT, MODIFIED	Helena Laboratories	1995-09-08	116
K951497	CASCASE 480 SNSLYZER	Helena Laboratories	1995-09-01	182
K946274	COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN	Helena Laboratories	1995-07-11	200
K950590	REP CHOLESTEROL PROFILE CONTROL	Helena Laboratories	1995-03-30	49
K950801	CARDIO REP LD CONTROL - CAT NO. 3325	Helena Laboratories	1995-03-30	37
K935169	APTT-ES	Helena Laboratories	1994-12-02	402
K941872	SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302	Helena Laboratories	1994-11-21	217

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