Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
2002 — Predicate Candidate Screening
3,685 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
71 daysmedian FDA review time
209 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023633 | SOVIS OPTIQUE'S ENDOSCOPIC CABLE | Sovis Optique | 2002-12-31 | 63 | 0 |
| K022466 | PROFILE 1320 LASER SYSTEM | Sciton, Inc | 2002-12-31 | 159 | 0 |
| K022249 | NIGHTRON POLYSOMNOGRAPHY SYSTEM | Telediagnostic Systems, Inc. | 2002-12-31 | 172 | 0 |
| K023334 | BMC CATHETER CONNECTOR CABLE, MODEL RFP-101 | Baylis Medical Co., Inc. | 2002-12-31 | 85 | 0 |
| K024084 | ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391 | Abbott Laboratories | 2002-12-31 | 20 | 0 |
| K024032 | ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART | Medtronic Vascular | 2002-12-30 | 24 | 0 |
| K024130 | POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, S | Wrp Asia Pacific Sdn. Bhd. | 2002-12-30 | 14 | 0 |
| K024035 | ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVE | Medtronic Vascular | 2002-12-30 | 24 | 0 |
| K022091 | BALDUR BRAND VINYL POWDER-FREE EXAMINATION GLOVES | Tangshan Zhonghong Pulin Group Co., Ltd. | 2002-12-30 | 186 | 0 |
| K010185 | 6.0 X 5.7MM DENTAL IMPLANT | Bicon, Inc. | 2002-12-30 | 710 | 0 |
| K022584 | CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING | Cardiotech Intl. | 2002-12-30 | 147 | 0 |
| K023769 | PREPARE ADMINISTRATION SET | Appro Healthcare, Inc. | 2002-12-30 | 48 | 0 |
| K024109 | BD ULTRA-FINE III PEN NEEDLE | Becton, Dickinson & CO | 2002-12-30 | 17 | 0 |
| K023545 | ULTRA-LITE 200E LIGHT CURE UNIT | Rolence Ent., Inc. | 2002-12-30 | 69 | 0 |
| K024058 | MODIFICATION TO CARDEON AEGIS CATHETER | Cardeon Corp. | 2002-12-30 | 21 | 0 |
| K024037 | NARROW ASCENT INTERLOK FEMORAL COMPONENTS | Biomet, Inc. | 2002-12-30 | 24 | 0 |
| K023656 | SICKLE-CHEX SOLUBILITY KIT | Streck Laboratories, Inc. | 2002-12-30 | 61 | 0 |
| K022009 | 3I IMPLANTS; OSSEOTITE DENTAL IMPLANTS; OSSEOTITE NT DENTAL | Implant Innovations, Inc. | 2002-12-30 | 194 | 0 |
| K022854 | ACELL UBM HYDRATED WOUND DRESSING | Acell, Inc. | 2002-12-30 | 137 | 0 |
| K020020 | THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS- | Well-Life Healthcare, Inc. | 2002-12-30 | 361 | 0 |
| K023993 | GALAXY SERIES WHEELCHAIR | Evermed Corp. | 2002-12-27 | 24 | 0 |
| K021987 | PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY | S&S Par Scientific | 2002-12-27 | 192 | 0 |
| K023372 | NON-BIOABSORBABLE STAPLE | Onux Medical, Inc. | 2002-12-27 | 80 | 0 |
| K023388 | MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM | Mitek Worldwide | 2002-12-27 | 79 | 0 |
| K023305 | KEGELMASTER 2000 | Kegelmaster 2000 , Ltd. | 2002-12-26 | 84 | 0 |
| K023807 | MODIFICATION TO ALKP | Abbott Laboratories | 2002-12-26 | 42 | 0 |
| K023222 | ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12 | Invitrocare, Inc. | 2002-12-26 | 90 | 0 |
| K022723 | MASTEL 1 FOLDER IMPLANTATION SYSTEM | Mastel Precision, Inc. | 2002-12-26 | 132 | 0 |
| K023259 | INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 | Helix Medical, Inc. | 2002-12-26 | 87 | 0 |
| K023841 | AMMONIA ASSAY FOR THE ADVIA 1650 | Bayer Diagnostics Corp. | 2002-12-24 | 36 | 0 |
| K023961 | SCOUT BOSS | Burke, Inc. | 2002-12-24 | 25 | 0 |
| K022517 | USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY | U-Systems, Inc. | 2002-12-24 | 147 | 0 |
| K024107 | FEMOSTOP FEMORAL COMPRESSION SYSTEM | Radi Medical Systems AB | 2002-12-24 | 11 | 0 |
| K023962 | NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-1 | New Star Lasers, Inc. | 2002-12-24 | 25 | 0 |
| K023731 | QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), | Consolidated Technology | 2002-12-24 | 48 | 0 |
| K023634 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-GENTAMICIN GN (0.25 | Becton, Dickinson & CO | 2002-12-24 | 56 | 0 |
| K023784 | RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBE | Hemagen Diagnostics, Inc. | 2002-12-24 | 42 | 0 |
| K023241 | TELEGRAPH HUMERAL NAIL | Fournitures Hospitalieres Industrie | 2002-12-24 | 85 | 0 |
| K021509 | HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 506 | Hygia Health Services, Inc. | 2002-12-24 | 229 | 0 |
| K023667 | RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE | Plus Orthopedics | 2002-12-24 | 54 | 0 |
| K023349 | CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS | Contamac, Ltd. | 2002-12-24 | 78 | 0 |
| K023370 | CHEETAH I.V.D.S., MODEL 2002P | Cheetah Medical, Inc. | 2002-12-24 | 77 | 0 |
| K023239 | AIA-PACK CA 19-9 | Tosoh Corp. | 2002-12-23 | 87 | 0 |
| K023247 | CHAMPION 5000 PERIPHERAL VASCULAR COIL | Usa Instruments, Inc. | 2002-12-23 | 84 | 0 |
| K023964 | RUSCH MICROLARYNGEAL TUBE | Rusch Intl. | 2002-12-23 | 24 | 0 |
| K022086 | AIM-V (R) MEDIUM, MODEL 087-0112 | Invitrogen Corporation | 2002-12-23 | 179 | 1 |
| K023396 | AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) | Pointe Scientific, Inc., | 2002-12-23 | 75 | 0 |
| K022690 | PAROS CRP | Horiba, Ltd. | 2002-12-23 | 132 | 0 |
| K023719 | MP-1 MICRO PERIMETER | Nidek Technologies Srl | 2002-12-23 | 48 | 0 |
| K023877 | Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATIO | Philips Ultrasound, Inc. | 2002-12-23 | 32 | 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