Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
2000 — Predicate Candidate Screening
3,453 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
72 daysmedian FDA review time
227 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992424 | SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN L | Plastimed Laboratoire Pharmaceutique | 2000-12-29 | 527 | 0 |
| K003240 | BIOMET EXTERNAL WRIST PLATE | Biomet, Inc. | 2000-12-29 | 73 | 0 |
| K002127 | INJECTRITE-C15 AND INJECTRITE-C30 | Sterling Medivations, Inc. | 2000-12-29 | 168 | 0 |
| K002182 | AVITA TSO/TS1 INFRARED EAR THERMOMETER | Avita Corporation | 2000-12-29 | 163 | 0 |
| K003212 | FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) | Disco-O-Tech Medical Technologies, Ltd. | 2000-12-28 | 76 | 0 |
| K003097 | BRAIN COIL, MODEL 9800GE-64 | Midwest Rf, LLC | 2000-12-28 | 86 | 0 |
| K003040 | INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPOR | Intratherapeutics, Inc. | 2000-12-28 | 90 | 0 |
| K001576 | EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY | Prosurg, Inc. | 2000-12-28 | 220 | 0 |
| K003386 | SPECIAL PROCEDURES HEAD COIL; MODEL # 1100GE-64 | Midwest Rf, LLC | 2000-12-28 | 58 | 0 |
| K001499 | PHORMAX EAGLE SCANNER SYSTEM | Phormax Corp. | 2000-12-27 | 226 | 0 |
| K003175 | COMPUMEDICS SIESTA SYSTEM | Compumedics Limited | 2000-12-27 | 78 | 0 |
| K003815 | TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER | Merits Health Products., Inc. | 2000-12-27 | 16 | 0 |
| K002803 | THE O'NEIL STERILE FIELD URINARY CATHETER KIT | Go Medical Industries Pty. , Ltd. | 2000-12-27 | 110 | 5 |
| K001738 | DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT | DePuy Orthopaedics, Inc. | 2000-12-27 | 203 | 0 |
| K001785 | SURGISIS PERIPHERAL VASCULAR PATCH | Cook Biotech, Inc. | 2000-12-27 | 197 | 1 |
| K003516 | GYROSCAN INTERA 3.0T | Philips Medical Systems North America, Inc. | 2000-12-27 | 43 | 0 |
| K003568 | XISCAN 6000 IMAGING SYSTEM | Xitec, Inc. | 2000-12-27 | 37 | 0 |
| K002031 | PHACOFRAGMENTATION SYSTEM MEGATRON | Asclepion-Meditec AG | 2000-12-27 | 177 | 0 |
| K003643 | NUMED Z-MED PTV CATHERERS | NuMED, Inc. | 2000-12-27 | 30 | 0 |
| K003739 | ALOKA SSD-4000 | Aloka Co., Ltd. | 2000-12-27 | 23 | 0 |
| K002830 | PELVIC MUSCLE THERAPY | Colonial Medical Supply | 2000-12-27 | 107 | 0 |
| K003215 | MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION | Disco-O-Tech Medical Technologies, Ltd. | 2000-12-27 | 75 | 0 |
| K002197 | CARTOUCH | Cardionics, Inc. | 2000-12-27 | 160 | 0 |
| K003230 | V SCORE WITH AUTO GATE MODEL TBD | Vital Images, Inc. | 2000-12-27 | 72 | 0 |
| K000396 | APNOESCREEN PRO, ALPHA SCREEN PRO | Erich Jaeger, Inc. | 2000-12-27 | 324 | 0 |
| K003372 | IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVIT | Diagnostic Products Corp. | 2000-12-26 | 57 | 0 |
| K003677 | ABX PENTRA 60C+ HEMATOLOGY ANALYZER | Abx Diagnostics | 2000-12-26 | 27 | 2 |
| K003050 | CRYOSURGICAL UNIT AND ACCESSORIES | Cryogen, Inc. | 2000-12-26 | 85 | 0 |
| K002449 | BIOTEQ I.V. (INTRAVENOUS) SET | Bioteque Corp. | 2000-12-22 | 135 | 0 |
| K000641 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2000-12-22 | 301 | 0 |
| K003635 | DW 276 #3 | Ivoclar North America, Inc. | 2000-12-22 | 28 | 0 |
| K003257 | EHC400 DESKTOP PATIENT STATION; ECH600 CARE PROVIDER STATION | Cybercare Technologies, Inc. | 2000-12-22 | 65 | 0 |
| K002976 | RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLO | St Jude Medical | 2000-12-22 | 88 | 0 |
| K003270 | PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189 | Nucletron Corp. | 2000-12-22 | 65 | 0 |
| K003687 | VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II | Medtox Diagnostics, Inc. | 2000-12-22 | 22 | 0 |
| K994279 | PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION) | Pure Water Solutions, Inc. | 2000-12-22 | 368 | 0 |
| K003305 | PEDIATRIC INGESTASCAN | Adams Electronics, Inc. | 2000-12-22 | 63 | 0 |
| K003134 | FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING | Adri/Technam | 2000-12-22 | 77 | 0 |
| K003685 | MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL | Medical Advances, Inc. | 2000-12-22 | 22 | 0 |
| K003769 | ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES, MODEL 87 | Ansell Healthcare Products, Inc. | 2000-12-22 | 16 | 0 |
| K003196 | SYNCHRON SYSTEMS AMMONIA REAGENT | Beckman Coulter, Inc. | 2000-12-22 | 71 | 0 |
| K003849 | GE ADVANCE NXI PET SYSTEM | Ge Medical Systems, Inc. | 2000-12-22 | 10 | 0 |
| K003036 | TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE | Retinalabs.Com | 2000-12-22 | 84 | 0 |
| K003790 | DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 555100 | Davol, Inc. | 2000-12-22 | 14 | 0 |
| K003265 | CLEANAIR/ CLEANWATER UNIT, MODEL 1600 | Texas Institute For Conservative Dentistry | 2000-12-22 | 65 | 0 |
| K003366 | MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL | Igc-Medical Advances, Inc. | 2000-12-22 | 53 | 0 |
| K001955 | AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A | Aaron Medical Industries | 2000-12-22 | 178 | 0 |
| K003243 | SIEMENS INFINITY MODULAR MONITORS MODEL SC 8000; SC 7000; SC | Siemens Medical Solutions USA, Inc. | 2000-12-21 | 65 | 0 |
| K984579 | CAPNO PROBE A | Optical Sensors, Inc. | 2000-12-21 | 729 | 0 |
| K003264 | QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATIO | Ge Medical Systems F.I. Haifa | 2000-12-21 | 64 | 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