Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

1999 — Predicate Candidate Screening

3,554 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.

77 daysmedian FDA review time

226 days90th percentile

2,000clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K994237	AT HOME DRUG TEST, MODEL 9063	Phamatech	1999-12-30	14	0
K994236	AT HOME DRUG TEST, MODEL 9133	Phamatech	1999-12-30	14	0
K993330	THERMOCHEM-HT SYSTEM	Hemocleanse, Inc.	1999-12-30	87	0
K993969	SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION	Winchester Laboratories, LLC	1999-12-30	37	0
K994220	AT HOME DRUG TEST, MODEL 9078	Phamatech	1999-12-30	15	0
K994234	AT HOME DRUG TEST, MODEL 9083	Phamatech	1999-12-30	14	0
K993232	WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY S	Boston Scientific Scimed, Inc.	1999-12-30	94	0
K994233	AT HOME DRUG TEST, MODEL 9068	Phamatech	1999-12-30	14	0
K994186	DISETRONIC D-TRON INSULIN INFUSION PUMP	Disetronic Medical Systems	1999-12-30	20	0
K994219	AT HOME DRUG TEST, MODEL 9073	Phamatech	1999-12-30	15	0
K993575	RESOLVE QUICKANCHOR	Mitek Products	1999-12-29	69	0
K992148	HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS	Morax	1999-12-29	188	0
K993288	SULZER CARBOMEDICS CARDIOFIX PERICARDIUM	Sulzer Carbomedics, Inc.	1999-12-29	89	0
K993542	ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL V	Rossmax International , Ltd.	1999-12-29	71	0
K993283	OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C	Arnold & Richter Cine Technik	1999-12-29	90	0
K993862	MODUS SAGITTAL SPLIT PLATE	The Straumann Co.	1999-12-29	44	0
K993338	INTEGRATED DIGITAL MEDICAL RECORD (IDMR)	Ibm Israel , Ltd.	1999-12-29	85	0
K993450	LATEX SURGICAL GLOVES, PRE-POWDERED	Fitco Dipped Products Pvt., Ltd.	1999-12-29	78	0
K993693	INVIGRA	Indus Medicare , Ltd.	1999-12-29	57	0
K993030	MODIFICATION TO ISOLA SPINAL SYSTEM	Depuyacromed	1999-12-29	113	0
K993621	HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAM	Pamitex Industries Sdn Bhd	1999-12-29	64	0
K993562	POWDER FREE LATEX STERILE SURGICAL GLOVES	Tg Medical Sdn. Bhd.	1999-12-29	69	0
K994197	DISENTRONIC PENFINE INJECTION PEN NEEDLE	Disetronic Medical Systems	1999-12-29	16	0
K992927	STEALTHSTATION TREATMENT GUIDANCE PLATFORM	Surgical Navigation Technologies, Inc.	1999-12-29	120	1
K993529	POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED WITH PR	Biografik (Malaysia) Sdn Bhd	1999-12-29	72	0
K991441	CADENCE DOPPLER ULTRASOUND SYSTEM	Medasonics, Inc.	1999-12-28	246	0
K993761	CARDIOVASCULAR MEASUREMENT SYSTEM - VIEW	Medis Medical Imaging Systems BV	1999-12-28	50	0
K993591	BLADEWORKS DISPOSABLE ALK TUBING	Blade Works, Inc.	1999-12-28	67	0
K991541	A-MED VASCULAR CANNULA, MODELS V24-10-08, V24-10-16, V24-10-	A-Med Systems, Inc.	1999-12-28	239	0
K993650	URETERAL ACCESS SHEATH SET - NEW MODELS	Applied Medical Resources	1999-12-28	60	0
K993643	NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100	Nexan Telemed , Ltd.	1999-12-28	61	0
K991562	PASCAL MEDICAL AB MENIETT 20	Pascal Medical AB	1999-12-28	238	0
K990959	K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM	Spineology, Inc.	1999-12-27	280	0
K993142	ELITE CUSTOM	Soma Blue, Inc.	1999-12-27	97	0
K992482	DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM)	Radiancy, Ltd.	1999-12-27	154	0
K993485	VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DE	Sun Biomedical Laboratories, Inc.	1999-12-27	74	0
K993993	HARDYDISK AMIKACIN 30MCG	Hardy Diagnostics	1999-12-27	33	0
K994149	MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGA	Bio-Logic Systems Corp.	1999-12-27	19	0
K994166	GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE	Gyrus Medical , Ltd.	1999-12-27	18	0
K993851	SODEM PERFORATOR DRIVE	Sodemsystems	1999-12-27	45	0
K993936	15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAS	Imagyn Surgical	1999-12-27	38	0
K983860	MTM BIOSCANNER K TEST STRIPS, CAT # BSA610	Polymer Technology Systems, Inc.	1999-12-27	420	0
K994075	GEIGER DISPOSABLE ELECTROSURGICAL ELECTRODE, MODEL 435	Geiger Medical Technologies, Inc.	1999-12-27	25	0
K993853	K-ASSAY MULTI-ANALYTE CALIBRATOR	Kamiya Biomedical Co.	1999-12-27	45	0
K993771	CARESIDE DIRECT BILIRUBIN	Careside, Inc.	1999-12-27	49	0
K993143	VITALITY SYSTEM	Soma Blue, Inc.	1999-12-27	97	0
K992949	SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST	Drug Detection Devices, Ltd.	1999-12-27	117	0
K992074	MPM REGENECARE WOUND GEL	Mpm Medical., Inc.	1999-12-23	188	0
K990079	FASTSEAL CHEST WOUND DRESSING	Greenfield Medical Technologies, Inc.	1999-12-23	346	0
K990416	OMNICORDER BIOSCAN SYSTEM	Omnicorder Technologies, Inc.	1999-12-23	316	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